OsteoporosisPaVOSNCT02563353
PTH and Vibration in OSteoporosis Study
A study testing whole-body vibration and teriparatide in people with Osteoporosis, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Objective: This is a randomized controlled trial (RCT) in osteoporosis patients randomized to standard parathyroid hormone (PTH) treatment alone or to standard PTH treatment and Whole-body vibration (WBV). PTH is an effective but expensive anabolic treatment for osteoporosis. WBV stimulates muscles and bones. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- whole-body vibration and teriparatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2015to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women starting PTH treatment for osteoporosis according to Danish Osteoporosis guidelines
Who cannot join
- Women currently taking oral glucocorticoids
- Women unable to give informed consent
- Women unable to stand for 2 minutes at a time on the vibration platform
- Women who have contraindications to WBV (e.g. joint prosthesis, pacemakers)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PTH and Vibration in OSteoporosis (PaVOS) Study
Objective:
This is a randomized controlled trial (RCT) in osteoporosis patients randomized to standard parathyroid hormone (PTH) treatment alone or to standard PTH treatment and Whole-body vibration (WBV). PTH is an effective but expensive anabolic treatment for osteoporosis. WBV stimulates muscles and bones. A combined treatment might have synergistic or additive beneficial effects on bone, reducing fracture risk making treatment more effective and cost-effective. A beneficial effect on muscles and thereby falls risk of WBV may improve fracture risk even further.
If the results of this pilot study are promising then a strong case can be made for a large multi-centre RCT using strong endpoints including fractures and falls.
Read the detailed description
Study Objectives
- To determine if WBV in addition to standard PTH treatment has a greater effect on bone mass in osteoporosis patients compared to standard PTH treatment alone.
- To determine if WBV in addition to standard PTH treatment has a greater effect on bone microarchitecture in osteoporosis patients compared to standard PTH treatment alone, as assessed by high resolution peripheral quantitative computed tomography (HR-pQCT).
- To determine if WBV in addition to standard PTH treatment has a greater effect on markers of bone formation and resorption in osteoporosis patients compared to standard PTH treatment alone.
- To study the effects of WBV on muscle function and balance in osteoporosis
- To assess the safety and adherence to WBV in osteoporotic patients
Study Design:
General Design This will be a multi-center randomized controlled trial (RCT) in osteoporosis patients being started on standard PTH treatment according to Danish Osteoporosis guidelines. Participants will be randomized to standard PTH treatment alone or to standard PTH treatment and WBV.
Statistical Plan:
Sample Size Determination The inclusion of 32 participants (16 in both groups) would give the study 80% power to detect a clinically significant additional increase of 22% with WBV (assuming a 9% increase of BMD in the PTH alone group and 11% increase in the combined PTH+WBV group, and assuming a SD of the BMD increase of 2%. Allowing for a 20% dropout rate, the plan is to include 40 participants (20 in each group). From previous research on WBV by one of the investigators (TM), statistically significant differences were found in bone formation markers and in muscle strength at 3 months between the WBV and control groups with a sample size of 35. The number of participants in the latter pilot work is reassuringly consistent with the sample size calculations. The number needed to be included is far less (34%) than the actual number of patients treated with PTH in the recruiting departments in a similar time period last year.
Statistical Methods:
STATA/SPSS will be used for data analysis. For the primary endpoint (BMD at 12 months) the mean percentage changes in BMD between the two groups will be compared using Analysis of Variance (ANOVA) provided the distribution is normal. For the other endpoints parametric tests will be used to assess differences in the two groups for normally distributed data and non-parametric tests for data not normally distributed.
The randomization will be done online in the data capture program Red Cap. There will be created a Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, and normal ranges if relevant.
Information:
Participants will be recruited during their attendance at the outpatient clinics. At that time the subjects will be given a full explanation of the study as well as the patient information sheet and invited to participate in the study. At an interval of not less than 24 hours, patients will be invited to consent prior to starting their PTH treatment.
The information will be sufficient for subjects to make an informed decision about their participation in this study. The subject will complete and sign a consent form to indicate they are giving valid consent to participate in the trial.
Withdrawal of Subjects:
Patients who withdraw consent from participation in the trial will be withdrawn from the trial. This will not affect their standard medical management and not cause any adverse effect on the subject.
- Conditions
- Osteoporosis
- Being tested
- whole-body vibration, teriparatide
- Keywords
- whole body vibration, PTH
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole-body vibrationOther
Also called vibration therapy
Whole-body vibration on vibration platforms. 30-40 Hertz, from 2 mm (low) to 4 mm (high) amplitude,
1 minutes x 6 with 1 minute break between. 3 times a week.
teriparatideDrug
Also called PTH
Teriparatide, 20 microgram/day. 24 months of treatment.
| Study group | Role | What they receive |
|---|---|---|
| controlgroup | Active comparator | Teriparatide, 20 microgram/day. 24 months of treatment Receives: Drug: teriparatide |
| studygroup 1 | Experimental | Teriparatide, 20 microgram/day. 24 months of treatment.
12 months of Whole-body vibration on vibration platforms. Receives: Other: whole-body vibration; Drug: teriparatide |
| studygroup 2 | Experimental | Teriparatide, 20 microgram/day. 24 months of treatment.
24 months of Whole-body vibration on vibration platforms Receives: Other: whole-body vibration; Drug: teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the BMD, Bone Mineral Density of hip and spine region (Hologic DXA machine)
DXA scan of hip and spine regions, BMD (g/cm^2)
Measured: at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18, 24 months from baseline
Secondary outcomes (13)
Changes in the Bone microarchitecture at the tibia
HRpQCT assesses parameters of bone microarchitecture at the tibia.
Measured: at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18 and 24 months from baseline
Changes in the Bone microarchitecture at the radius
HRpQCT assesses parameters of bone microarchitecture at the radius.
Measured: at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18 and 24 months from baseline
changes in muscle mass
Full body DXA
Measured: at the time the participants start treatment and in an interval as close as possible to after 12 and 24 months from baseline
Changes from baseline in the markers of bone resorption
CTX, sclerostin
Measured: at the time the participants start treatment and in an interval as close as possible to after 3, 6, 12, 18, 24 months from baseline
Changes from baseline in the markers of bone formation
P1NP
Measured: at the time the participants start treatment and in an interval as close as possible to after 3, 6, 12, 18, 24 months from baseline
Changes in Muscle strength
Measurements of muscle strength (leg extensor power)
Measured: at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline
Changes in handgrip strength
Measurements of muscle strength (handgrip strength)
Measured: at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline
Changes in Balance
Short Physical Performance Battery (SPPB)
Measured: at the time the participants start treatment and in an interval as close as possible to after 3, 6 ,12, 18 and 24 months from baseline
Adherence to WBV
Self Reporting training log
Measured: During 2 years from the start of the treatment
Changes in physical activity
IPAQ short version
Measured: at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline
Changes in quality of life
EQ5D questionaire.
Measured: at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline
Changes in basic mobility
Time up and go test
Measured: at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline
Changes in The Falls Efficacy Scale International
FES-I
Measured: at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2018
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Copenhagen University Hospital, Denmark, Esbjerg Hospital - University Hospital of Southern Denmark, Sygehus Lillebaelt, Odense Patient Data Explorative Network, Region of Southern Denmark
- Responsible party
- Principal investigator, Lars Matzen, Odense University Hospital
- Investigators
- Lars Matzen, Clin.Ass.Pro, Principal investigator, Odense University HospitalDitte Jepsen, MD, ph.d. student, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563353
- Sponsor's protocol ID
- S-20150121
- Acronym
- PaVOS
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2015
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
O'Neill TW, Cockerill W, Matthis C, Raspe HH, Lunt M, Cooper C, Banzer D, Cannata JB, Naves M, Felsch B, Felsenberg D, Janott J, Johnell O, Kanis JA, Kragl G, Lopes Vaz A, Lyritis G, Masaryk P, Poor G, Reid DM, Reisinger W, Scheidt-Nave C, Stepan JJ, Todd CJ, Woolf AD, Reeve J, Silman AJ. Back pain, disability, and radiographic vertebral fracture in European women: a prospective study. Osteoporos Int. 2004 Sep;15(9):760-5. doi: 10.1007/s00198-004-1615-4. Epub 2004 May 12.
PubMed 15138664Cockerill W, Lunt M, Silman AJ, Cooper C, Lips P, Bhalla AK, Cannata JB, Eastell R, Felsenberg D, Gennari C, Johnell O, Kanis JA, Kiss C, Masaryk P, Naves M, Poor G, Raspe H, Reid DM, Reeve J, Stepan J, Todd C, Woolf AD, O'Neill TW. Health-related quality of life and radiographic vertebral fracture. Osteoporos Int. 2004 Feb;15(2):113-9. doi: 10.1007/s00198-003-1547-4. Epub 2003 Nov 13.
PubMed 14618303Tosteson AN, Gabriel SE, Grove MR, Moncur MM, Kneeland TS, Melton LJ 3rd. Impact of hip and vertebral fractures on quality-adjusted life years. Osteoporos Int. 2001 Dec;12(12):1042-9. doi: 10.1007/s001980170015.
PubMed 11846331Borgstrom F, Zethraeus N, Johnell O, Lidgren L, Ponzer S, Svensson O, Abdon P, Ornstein E, Lunsjo K, Thorngren KG, Sernbo I, Rehnberg C, Jonsson B. Costs and quality of life associated with osteoporosis-related fractures in Sweden. Osteoporos Int. 2006;17(5):637-50. doi: 10.1007/s00198-005-0015-8. Epub 2005 Nov 9.
PubMed 16283064Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007 Mar;22(3):465-75. doi: 10.1359/jbmr.061113.
PubMed 17144789Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, Hodsman AB, Eriksen EF, Ish-Shalom S, Genant HK, Wang O, Mitlak BH. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001 May 10;344(19):1434-41. doi: 10.1056/NEJM200105103441904.
PubMed 11346808Blick SK, Dhillon S, Keam SJ. Teriparatide: a review of its use in osteoporosis. Drugs. 2008;68(18):2709-37. doi: 10.2165/0003495-200868180-00012.
PubMed 19093708Bergmann P, Body JJ, Boonen S, Boutsen Y, Devogelaer JP, Goemaere S, Kaufman J, Reginster JY, Rozenberg S. Loading and skeletal development and maintenance. J Osteoporos. 2010 Dec 20;2011:786752. doi: 10.4061/2011/786752.
PubMed 21209784Lewis RD, Modlesky CM. Nutrition, physical activity, and bone health in women. Int J Sport Nutr. 1998 Sep;8(3):250-84. doi: 10.1123/ijsn.8.3.250.
PubMed 9738135Rizzoli R, Bianchi ML, Garabedian M, McKay HA, Moreno LA. Maximizing bone mineral mass gain during growth for the prevention of fractures in the adolescents and the elderly. Bone. 2010 Feb;46(2):294-305. doi: 10.1016/j.bone.2009.10.005. Epub 2009 Oct 17.
PubMed 19840876Chow JW, Fox S, Jagger CJ, Chambers TJ. Role for parathyroid hormone in mechanical responsiveness of rat bone. Am J Physiol. 1998 Jan;274(1):E146-54. doi: 10.1152/ajpendo.1998.274.1.E146.
PubMed 9458760Li J, Duncan RL, Burr DB, Gattone VH, Turner CH. Parathyroid hormone enhances mechanically induced bone formation, possibly involving L-type voltage-sensitive calcium channels. Endocrinology. 2003 Apr;144(4):1226-33. doi: 10.1210/en.2002-220821.
PubMed 12639904Roberts MD, Santner TJ, Hart RT. Local bone formation due to combined mechanical loading and intermittent hPTH-(1-34) treatment and its correlation to mechanical signal distributions. J Biomech. 2009 Nov 13;42(15):2431-8. doi: 10.1016/j.jbiomech.2009.08.030. Epub 2009 Sep 26.
PubMed 19782988Wysocki A, Butler M, Shamliyan T, Kane RL. Whole-body vibration therapy for osteoporosis: state of the science. Ann Intern Med. 2011 Nov 15;155(10):680-6, W206-13. doi: 10.7326/0003-4819-155-10-201111150-00006.
PubMed 22084334Gusi N, Raimundo A, Leal A. Low-frequency vibratory exercise reduces the risk of bone fracture more than walking: a randomized controlled trial. BMC Musculoskelet Disord. 2006 Nov 30;7:92. doi: 10.1186/1471-2474-7-92.
PubMed 17137514
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTH and Vibration in OSteoporosis (PaVOS) Study
- ClinicalTrials.gov ID
- NCT02563353
- Acronym / sponsor ID
- PaVOS / S-20150121
- Conditions
- Osteoporosis
- Keywords
- whole body vibration, PTH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Copenhagen University Hospital, Denmark, Esbjerg Hospital - University Hospital of Southern Denmark, Sygehus Lillebaelt, Odense Patient Data Explorative Network, Region of Southern Denmark
- Study start
- Nov 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective:
This is a randomized controlled trial (RCT) in osteoporosis patients randomized to standard parathyroid hormone (PTH) treatment alone or to standard PTH treatment and Whole-body vibration (WBV). PTH is an effective but expensive anabolic treatment for osteoporosis. WBV stimulates muscles and bones. A combined treatment might have synergistic or additive beneficial effects on bone, reducing fracture risk making treatment more effective and cost-effective. A beneficial effect on muscles and thereby falls risk of WBV may improve fracture risk even further.
If the results of this pilot study are promising then a strong case can be made for a large multi-centre RCT using strong endpoints including fractures and falls.
Detailed description
Study Objectives
- To determine if WBV in addition to standard PTH treatment has a greater effect on bone mass in osteoporosis patients compared to standard PTH treatment alone.
- To determine if WBV in addition to standard PTH treatment has a greater effect on bone microarchitecture in osteoporosis patients compared to standard PTH treatment alone, as assessed by high resolution peripheral quantitative computed tomography (HR-pQCT).
- To determine if WBV in addition to standard PTH treatment has a greater effect on markers of bone formation and resorption in osteoporosis patients compared to standard PTH treatment alone.
- To study the effects of WBV on muscle function and balance in osteoporosis
- To assess the safety and adherence to WBV in osteoporotic patients
Study Design:
General Design This will be a multi-center randomized controlled trial (RCT) in osteoporosis patients being started on standard PTH treatment according to Danish Osteoporosis guidelines. Participants will be randomized to standard PTH treatment alone or to standard PTH treatment and WBV.
Statistical Plan:
Sample Size Determination The inclusion of 32 participants (16 in both groups) would give the study 80% power to detect a clinically significant additional increase of 22% with WBV (assuming a 9% increase of BMD in the PTH alone group and 11% increase in the combined PTH+WBV group, and assuming a SD of the BMD increase of 2%. Allowing for a 20% dropout rate, the plan is to include 40 participants (20 in each group). From previous research on WBV by one of the investigators (TM), statistically significant differences were found in bone formation markers and in muscle strength at 3 months between the WBV and control groups with a sample size of 35. The number of participants in the latter pilot work is reassuringly consistent with the sample size calculations. The number needed to be included is far less (34%) than the actual number of patients treated with PTH in the recruiting departments in a similar time period last year.
Statistical Methods:
STATA/SPSS will be used for data analysis. For the primary endpoint (BMD at 12 months) the mean percentage changes in BMD between the two groups will be compared using Analysis of Variance (ANOVA) provided the distribution is normal. For the other endpoints parametric tests will be used to assess differences in the two groups for normally distributed data and non-parametric tests for data not normally distributed.
The randomization will be done online in the data capture program Red Cap. There will be created a Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, and normal ranges if relevant.
Information:
Participants will be recruited during their attendance at the outpatient clinics. At that time the subjects will be given a full explanation of the study as well as the patient information sheet and invited to participate in the study. At an interval of not less than 24 hours, patients will be invited to consent prior to starting their PTH treatment.
The information will be sufficient for subjects to make an informed decision about their participation in this study. The subject will complete and sign a consent form to indicate they are giving valid consent to participate in the trial.
Withdrawal of Subjects:
Patients who withdraw consent from participation in the trial will be withdrawn from the trial. This will not affect their standard medical management and not cause any adverse effect on the subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| controlgroup | Active comparator | Drug: teriparatideTeriparatide, 20 microgram/day. 24 months of treatment |
| studygroup 1 | Experimental | Other: whole-body vibration, Drug: teriparatideTeriparatide, 20 microgram/day. 24 months of treatment. 12 months of Whole-body vibration on vibration platforms. |
| studygroup 2 | Experimental | Other: whole-body vibration, Drug: teriparatideTeriparatide, 20 microgram/day. 24 months of treatment. 24 months of Whole-body vibration on vibration platforms |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women starting PTH treatment for osteoporosis according to Danish Osteoporosis guidelines
Key exclusion criteria (4 listed)
- Women currently taking oral glucocorticoids
- Women unable to give informed consent
- Women unable to stand for 2 minutes at a time on the vibration platform
- Women who have contraindications to WBV (e.g. joint prosthesis, pacemakers)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole-body vibrationAlso: vibration therapyWhole-body vibration on vibration platforms. 30-40 Hertz, from 2 mm (low) to 4 mm (high) amplitude, 1 minutes x 6 with 1 minute break between. 3 times a week. | Other | studygroup 1, studygroup 2 |
| teriparatideAlso: PTHTeriparatide, 20 microgram/day. 24 months of treatment. | Drug | controlgroup, studygroup 1, studygroup 2 |
Primary outcome
Changes in the BMD, Bone Mineral Density of hip and spine region (Hologic DXA machine)
Time frame: at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18, 24 months from baseline
DXA scan of hip and spine regions, BMD (g/cm^2)
13 secondary outcomes
Changes in the Bone microarchitecture at the tibia
Time frame: at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18 and 24 months from baseline
Changes in the Bone microarchitecture at the radius
Time frame: at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18 and 24 months from baseline
changes in muscle mass
Time frame: at the time the participants start treatment and in an interval as close as possible to after 12 and 24 months from baseline
Changes from baseline in the markers of bone resorption
Time frame: at the time the participants start treatment and in an interval as close as possible to after 3, 6, 12, 18, 24 months from baseline
Changes from baseline in the markers of bone formation
Time frame: at the time the participants start treatment and in an interval as close as possible to after 3, 6, 12, 18, 24 months from baseline
Changes in Muscle strength
Time frame: at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline
Changes in handgrip strength
Time frame: at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline
Changes in Balance
Time frame: at the time the participants start treatment and in an interval as close as possible to after 3, 6 ,12, 18 and 24 months from baseline
Adherence to WBV
Time frame: During 2 years from the start of the treatment
Changes in physical activity
Time frame: at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline
Changes in quality of life
Time frame: at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline
Changes in basic mobility
Time frame: at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline
Changes in The Falls Efficacy Scale International
Time frame: at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Background: PubMed 15138664O'Neill TW, Cockerill W, Matthis C, Raspe HH, Lunt M, Cooper C, Banzer D, Cannata JB, Naves M, Felsch B, Felsenberg D, Janott J, Johnell O, Kanis JA, Kragl G, Lopes Vaz A, Lyritis G, Masaryk P, Poor G, Reid DM, Reisinger W, Scheidt-Nave C, Stepan JJ, Todd CJ, Woolf AD, Reeve J, Silman AJ. Back pain, disability, and radiographic vertebral fracture in European women: a prospective study. Osteoporos Int. 2004 Sep;15(9):760-5. doi: 10.1007/s00198-004-1615-4. Epub 2004 May 12.
- Background: PubMed 14618303Cockerill W, Lunt M, Silman AJ, Cooper C, Lips P, Bhalla AK, Cannata JB, Eastell R, Felsenberg D, Gennari C, Johnell O, Kanis JA, Kiss C, Masaryk P, Naves M, Poor G, Raspe H, Reid DM, Reeve J, Stepan J, Todd C, Woolf AD, O'Neill TW. Health-related quality of life and radiographic vertebral fracture. Osteoporos Int. 2004 Feb;15(2):113-9. doi: 10.1007/s00198-003-1547-4. Epub 2003 Nov 13.
- Background: PubMed 11846331Tosteson AN, Gabriel SE, Grove MR, Moncur MM, Kneeland TS, Melton LJ 3rd. Impact of hip and vertebral fractures on quality-adjusted life years. Osteoporos Int. 2001 Dec;12(12):1042-9. doi: 10.1007/s001980170015.
- Background: PubMed 16283064Borgstrom F, Zethraeus N, Johnell O, Lidgren L, Ponzer S, Svensson O, Abdon P, Ornstein E, Lunsjo K, Thorngren KG, Sernbo I, Rehnberg C, Jonsson B. Costs and quality of life associated with osteoporosis-related fractures in Sweden. Osteoporos Int. 2006;17(5):637-50. doi: 10.1007/s00198-005-0015-8. Epub 2005 Nov 9.
- Background: PubMed 17144789Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007 Mar;22(3):465-75. doi: 10.1359/jbmr.061113.
- Background: PubMed 11346808Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, Hodsman AB, Eriksen EF, Ish-Shalom S, Genant HK, Wang O, Mitlak BH. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001 May 10;344(19):1434-41. doi: 10.1056/NEJM200105103441904.
- Background: PubMed 19093708Blick SK, Dhillon S, Keam SJ. Teriparatide: a review of its use in osteoporosis. Drugs. 2008;68(18):2709-37. doi: 10.2165/0003495-200868180-00012.
- Background: PubMed 21209784Bergmann P, Body JJ, Boonen S, Boutsen Y, Devogelaer JP, Goemaere S, Kaufman J, Reginster JY, Rozenberg S. Loading and skeletal development and maintenance. J Osteoporos. 2010 Dec 20;2011:786752. doi: 10.4061/2011/786752.
- Background: PubMed 9738135Lewis RD, Modlesky CM. Nutrition, physical activity, and bone health in women. Int J Sport Nutr. 1998 Sep;8(3):250-84. doi: 10.1123/ijsn.8.3.250.
- Background: PubMed 19840876Rizzoli R, Bianchi ML, Garabedian M, McKay HA, Moreno LA. Maximizing bone mineral mass gain during growth for the prevention of fractures in the adolescents and the elderly. Bone. 2010 Feb;46(2):294-305. doi: 10.1016/j.bone.2009.10.005. Epub 2009 Oct 17.
- Background: PubMed 9458760Chow JW, Fox S, Jagger CJ, Chambers TJ. Role for parathyroid hormone in mechanical responsiveness of rat bone. Am J Physiol. 1998 Jan;274(1):E146-54. doi: 10.1152/ajpendo.1998.274.1.E146.
- Background: PubMed 12639904Li J, Duncan RL, Burr DB, Gattone VH, Turner CH. Parathyroid hormone enhances mechanically induced bone formation, possibly involving L-type voltage-sensitive calcium channels. Endocrinology. 2003 Apr;144(4):1226-33. doi: 10.1210/en.2002-220821.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Matzen, Clin.Ass.Pro principal investigator
Odense University Hospital
Ditte Jepsen, MD, ph.d. student principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole-body vibration and teriparatide in people with Osteoporosis, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the BMD, Bone Mineral Density of hip and spine region (Hologic DXA machine) (time frame: at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18, 24 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02563353, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.