Vibration TherapyNCT04180267
RCT of Vibration Effect on Vertebral BMD in Disabled Patients
A study testing Low-magnitude High-frequency Vibration in people with Vibration Therapy and Wheelchair, run by Chinese University of Hong Kong at 3 sites in Hong Kong.
Trial summary
Osteoporosis is an age-related disease with progressive loss of bone, leading to fragile bone. It is one of the major health issues in elderly and causes medical, social and economic impacts globally. Patients with osteoporosis have high risk of osteoporotic fractures. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Vibration Therapy, Wheelchair, Osteoporosis
- What is being tested?
- Low-magnitude High-frequency Vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesHong Kong
- Study dates
- 19 Jul 2019to 8 Feb 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects of both genders aged ≥ 65 years
- Wheelchair users with walking difficulties
- Subjects with good general health conditions
Who cannot join
- Subjects cannot stand and walk independently
- Subjects who had vibration treatment before
- Subjects with malignancy
- Subjects with acute fractures or severe osteoarthritis
- Subjects with cardiovascular concern such as with pace-maker in-situ
- Subjects with chronic inflammatory conditions known to affect muscle metabolism such as rheumatoid arthritis
- Subjects with high frequency of physical activities, such as subjects who participated in regular exercise five times a week or more
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
ELCHK, Shan King Care And Attention Home For The Elderly
Hong Kong
Evangelical Lutheran Church Social Service - Hong Kong
Hong Kong
Sun Chui Lutheran Centre For The Elderly
Hong Kong
About this study
Official title: Efficacy of Low-magnitude High-frequency Vibration (LMHFV) on Musculoskeletal Health of Subjects on Wheelchair, a Randomized Controlled Study.
Osteoporosis is an age-related disease with progressive loss of bone, leading to fragile bone. It is one of the major health issues in elderly and causes medical, social and economic impacts globally. Patients with osteoporosis have high risk of osteoporotic fractures. Low-magnitude high-frequency vibration (LMHFV) is a non-invasive biophysical intervention providing whole-body mechanical stimulation. Previous studies showed that LMHFV is beneficial to muscle strength(1), postural control(2), balancing ability(3, 4), new bone formation(5-7), spinal bone mineral density (BMD)(8), and blood circulation(9). During the LMHFV treatment, elderly needs to stand upright on the platform for 20min/day. However, some elderlies with poor standing ability cannot stand for a long period. Therefore, the design of vibration platform is modified for the disabled patients and the efficacy of LMHFV on this group of elderlies will be verified. It is hypothesized that new design of LMHFV is beneficial to wheelchair users in terms of vertebral bone mineral density, muscle health and musculoskeletal functions.
Read the detailed description
This study is a single-blinded randomized controlled trial to investigate the effect of LMHFV on vertebral BMD, muscle health, balancing ability and functional ability in wheelchair users (mainly on wheelchair for outdoor activities).
Healthy elderlies aged 65 years or above, with walking difficulties and using wheelchair are eligible. We exclude anyone who: [1] cannot stand and walk independently, [2] have vibration treatment before, [3] with malignancy, [4] with acute fractures or severe osteoarthritis (18), [5] with cardiovascular concern such as with pace-maker in-situ, [6] with chronic inflammatory conditions known to affect muscle metabolism such as rheumatoid arthritis, and [7] with high frequency of physical activities, such as subjects who participated in regular exercise five times a week or more.
Recruited subjects will be randomized to either LMHFV or control group. Subject assigned to LMHFV group will receive LMHFV (35Hz, 0.3g, 20min/day, at least 3 times/week) for 6 months. The primary outcome is BMD at the lumbar spine to be assessed by dual-energy X-ray absorptiometry (DXA) that is clinically recommended for the diagnosis of osteoporosis. All primary and secondary outcome assessments for all groups will be performed in the investigators' institute at baseline and 6 months post-treatment.
- Conditions
- Vibration Therapy, Wheelchair, Osteoporosis
- Being tested
- Low-magnitude High-frequency Vibration
- Keywords
- Osteoporosis, Vibration Therapy, Disabled patient, Vertebral BMD
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-magnitude High-frequency VibrationDevice
Also called Vibration Treatment
35Hz, 0.3g, 20min/day, at least 3 times/week
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Subject assigned to Control Group will not receive LMHFV |
| LMHFV group | Active comparator | Subject assigned to LMHFV group will receive LMHFV (35Hz, 0.3g, 20min/day, at least 3 times/week) for half year. Receives: Device: Low-magnitude High-frequency Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertebral BMD
BMD will be assessed by standard DXA equipment (Delphi W, Hologic, Waltham, MA, USA) which is a gold standard assessment for osteoporosis recommended by World Health Organization (WHO). Spine and hip are the two sites used for the diagnosis of osteoporosis and will be both performed.
Measured: Half year
Secondary outcomes (4)
Muscle strength assessment
Handgrip strength and quadriceps strength
Measured: Half year
Modified functional reach test
Fall risk assessment for dynamic sitting balance
Measured: Half year
Biodex Balance System
Postural stability test
Measured: Half year
36-item Short-Form Health Survey (SF-36)
Assessment of health-related quality of life
Measured: Half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start19 Jul 2019
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Why it stopped: Discontinued due to COVID, community centres unable to provide services
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Vibration TherapyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subject will be randomized to either LMHFV group or control group. Subject assigned to LMHFV group will receive Low-magnitude High-frequency Vibration (35Hz, 0.3g, 20min/day, at least 3 times/week) for half year. The primary outcome is the effect of LMHFV on BMD at the lumbar spine, it will be assessed by dual-energy X-ray absorptiometry (DXA) that is clinically recommended for the diagnosis of osteoporosis. Secondary outcomes include muscle strength assessment, balancing ability and quality of life (QoL). All primary and secondary outcome assessments for all groups will be performed in the investigators' institute at baseline and 6 months post treatment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- V-Health Limited
- Responsible party
- Principal investigator, Professor CHEUNG Wing hoi, Louis, Chinese University of Hong Kong
- Investigators
- Wing-hoi CHEUNG, Prof, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180267
- Sponsor's protocol ID
- CREC 2019.087
- Status last verified
- Feb 2025
- First submitted
- 26 Nov 2019
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torvinen S, Kannus P, Sievanen H, Jarvinen TA, Pasanen M, Kontulainen S, Nenonen A, Jarvinen TL, Paakkala T, Jarvinen M, Vuori I. Effect of 8-month vertical whole body vibration on bone, muscle performance, and body balance: a randomized controlled study. J Bone Miner Res. 2003 May;18(5):876-84. doi: 10.1359/jbmr.2003.18.5.876.
PubMed 12733727Rubin C, Recker R, Cullen D, Ryaby J, McCabe J, McLeod K. Prevention of postmenopausal bone loss by a low-magnitude, high-frequency mechanical stimuli: a clinical trial assessing compliance, efficacy, and safety. J Bone Miner Res. 2004 Mar;19(3):343-51. doi: 10.1359/JBMR.0301251. Epub 2003 Dec 22.
PubMed 15040821Verschueren SM, Roelants M, Delecluse C, Swinnen S, Vanderschueren D, Boonen S. Effect of 6-month whole body vibration training on hip density, muscle strength, and postural control in postmenopausal women: a randomized controlled pilot study. J Bone Miner Res. 2004 Mar;19(3):352-9. doi: 10.1359/JBMR.0301245. Epub 2003 Dec 22.
PubMed 15040822Stewart JM, Karman C, Montgomery LD, McLeod KJ. Plantar vibration improves leg fluid flow in perimenopausal women. Am J Physiol Regul Integr Comp Physiol. 2005 Mar;288(3):R623-9. doi: 10.1152/ajpregu.00513.2004. Epub 2004 Oct 7.
PubMed 15472009Mithal A, Bansal B, Kyer CS, Ebeling P. The Asia-Pacific Regional Audit-Epidemiology, Costs, and Burden of Osteoporosis in India 2013: A report of International Osteoporosis Foundation. Indian J Endocrinol Metab. 2014 Jul;18(4):449-54. doi: 10.4103/2230-8210.137485. No abstract available.
PubMed 25143898Morse LR, Nguyen N, Battaglino RA, Guarino AJ, Gagnon DR, Zafonte R, Garshick E. Wheelchair use and lipophilic statin medications may influence bone loss in chronic spinal cord injury: findings from the FRASCI-bone loss study. Osteoporos Int. 2016 Dec;27(12):3503-3511. doi: 10.1007/s00198-016-3678-4. Epub 2016 Jul 13.
PubMed 27412619Paleg G, Livingstone R. Systematic review and clinical recommendations for dosage of supported home-based standing programs for adults with stroke, spinal cord injury and other neurological conditions. BMC Musculoskelet Disord. 2015 Nov 17;16:358. doi: 10.1186/s12891-015-0813-x.
PubMed 26576548Menendez H, Ferrero C, Martin-Hernandez J, Figueroa A, Marin PJ, Herrero AJ. Acute effects of simultaneous electromyostimulation and vibration on leg blood flow in spinal cord injury. Spinal Cord. 2016 May;54(5):383-9. doi: 10.1038/sc.2015.181. Epub 2015 Oct 13.
PubMed 26458973Gao KL, Chan KM, Purves S, Tsang WWN. Reliability of dynamic sitting balance tests and their correlations with functional mobility for wheelchair users with chronic spinal cord injury. J Orthop Translat. 2014 Aug 7;3(1):44-49. doi: 10.1016/j.jot.2014.07.003. eCollection 2015 Jan.
PubMed 30035039Williams B, Allen B, Hu Z, True H, Cho J, Harris A, Fell N, Sartipi M. Real-Time Fall Risk Assessment Using Functional Reach Test. Int J Telemed Appl. 2017;2017:2042974. doi: 10.1155/2017/2042974. Epub 2017 Jan 10.
PubMed 28167961Ruhe A, Fejer R, Walker B. Center of pressure excursion as a measure of balance performance in patients with non-specific low back pain compared to healthy controls: a systematic review of the literature. Eur Spine J. 2011 Mar;20(3):358-68. doi: 10.1007/s00586-010-1543-2. Epub 2010 Aug 19.
PubMed 20721676Lam CL, Gandek B, Ren XS, Chan MS. Tests of scaling assumptions and construct validity of the Chinese (HK) version of the SF-36 Health Survey. J Clin Epidemiol. 1998 Nov;51(11):1139-47. doi: 10.1016/s0895-4356(98)00105-x.
PubMed 9817131Roelants M, Delecluse C, Verschueren SM. Whole-body-vibration training increases knee-extension strength and speed of movement in older women. J Am Geriatr Soc. 2004 Jun;52(6):901-8. doi: 10.1111/j.1532-5415.2004.52256.x.
PubMed 15161453Rogan S, Hilfiker R, Herren K, Radlinger L, de Bruin ED. Effects of whole-body vibration on postural control in elderly: a systematic review and meta-analysis. BMC Geriatr. 2011 Nov 3;11:72. doi: 10.1186/1471-2318-11-72.
PubMed 22054046Cheung WH, Mok HW, Qin L, Sze PC, Lee KM, Leung KS. High-frequency whole-body vibration improves balancing ability in elderly women. Arch Phys Med Rehabil. 2007 Jul;88(7):852-7. doi: 10.1016/j.apmr.2007.03.028.
PubMed 17601464
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low-magnitude High-frequency Vibration (LMHFV) on Musculoskeletal Health of Subjects on Wheelchair, a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04180267
- Acronym / sponsor ID
- CREC 2019.087
- Conditions
- Vibration Therapy, Wheelchair, Osteoporosis
- Keywords
- Osteoporosis, Vibration Therapy, Disabled patient, Vertebral BMD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinued due to COVID, community centres unable to provide services
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- V-Health Limited
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 27 Nov 2019 (actual)
- 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.
Osteoporosis is an age-related disease with progressive loss of bone, leading to fragile bone. It is one of the major health issues in elderly and causes medical, social and economic impacts globally. Patients with osteoporosis have high risk of osteoporotic fractures. Low-magnitude high-frequency vibration (LMHFV) is a non-invasive biophysical intervention providing whole-body mechanical stimulation. Previous studies showed that LMHFV is beneficial to muscle strength(1), postural control(2), balancing ability(3, 4), new bone formation(5-7), spinal bone mineral density (BMD)(8), and blood circulation(9). During the LMHFV treatment, elderly needs to stand upright on the platform for 20min/day. However, some elderlies with poor standing ability cannot stand for a long period. Therefore, the design of vibration platform is modified for the disabled patients and the efficacy of LMHFV on this group of elderlies will be verified. It is hypothesized that new design of LMHFV is beneficial to wheelchair users in terms of vertebral bone mineral density, muscle health and musculoskeletal functions.
Detailed description
This study is a single-blinded randomized controlled trial to investigate the effect of LMHFV on vertebral BMD, muscle health, balancing ability and functional ability in wheelchair users (mainly on wheelchair for outdoor activities).
Healthy elderlies aged 65 years or above, with walking difficulties and using wheelchair are eligible. We exclude anyone who: [1] cannot stand and walk independently, [2] have vibration treatment before, [3] with malignancy, [4] with acute fractures or severe osteoarthritis (18), [5] with cardiovascular concern such as with pace-maker in-situ, [6] with chronic inflammatory conditions known to affect muscle metabolism such as rheumatoid arthritis, and [7] with high frequency of physical activities, such as subjects who participated in regular exercise five times a week or more.
Recruited subjects will be randomized to either LMHFV or control group. Subject assigned to LMHFV group will receive LMHFV (35Hz, 0.3g, 20min/day, at least 3 times/week) for 6 months. The primary outcome is BMD at the lumbar spine to be assessed by dual-energy X-ray absorptiometry (DXA) that is clinically recommended for the diagnosis of osteoporosis. All primary and secondary outcome assessments for all groups will be performed in the investigators' institute at baseline and 6 months post-treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subject will be randomized to either LMHFV group or control group. Subject assigned to LMHFV group will receive Low-magnitude High-frequency Vibration (35Hz, 0.3g, 20min/day, at least 3 times/week) for half year. The primary outcome is the effect of LMHFV on BMD at the lumbar spine, it will be assessed by dual-energy X-ray absorptiometry (DXA) that is clinically recommended for the diagnosis of osteoporosis. Secondary outcomes include muscle strength assessment, balancing ability and quality of life (QoL). All primary and secondary outcome assessments for all groups will be performed in the investigators' institute at baseline and 6 months post treatment.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Subject assigned to Control Group will not receive LMHFV |
| LMHFV group | Active comparator | Device: Low-magnitude High-frequency VibrationSubject assigned to LMHFV group will receive LMHFV (35Hz, 0.3g, 20min/day, at least 3 times/week) for half year. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Subjects of both genders aged ≥ 65 years
- Wheelchair users with walking difficulties
- Subjects with good general health conditions
Key exclusion criteria (7 listed)
- Subjects cannot stand and walk independently
- Subjects who had vibration treatment before
- Subjects with malignancy
- Subjects with acute fractures or severe osteoarthritis
- Subjects with cardiovascular concern such as with pace-maker in-situ
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 |
|---|---|---|
| Low-magnitude High-frequency VibrationAlso: Vibration Treatment35Hz, 0.3g, 20min/day, at least 3 times/week | Device | LMHFV group |
Primary outcome
Vertebral BMD
Time frame: Half year
BMD will be assessed by standard DXA equipment (Delphi W, Hologic, Waltham, MA, USA) which is a gold standard assessment for osteoporosis recommended by World Health Organization (WHO). Spine and hip are the two sites used for the diagnosis of osteoporosis and will be both performed.
4 secondary outcomes
Muscle strength assessment
Time frame: Half year
Modified functional reach test
Time frame: Half year
Biodex Balance System
Time frame: Half year
36-item Short-Form Health Survey (SF-36)
Time frame: Half year
Results and safety
The study was stopped early (reason given: Discontinued due to COVID, community centres unable to provide services). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Background: PubMed 12733727Torvinen S, Kannus P, Sievanen H, Jarvinen TA, Pasanen M, Kontulainen S, Nenonen A, Jarvinen TL, Paakkala T, Jarvinen M, Vuori I. Effect of 8-month vertical whole body vibration on bone, muscle performance, and body balance: a randomized controlled study. J Bone Miner Res. 2003 May;18(5):876-84. doi: 10.1359/jbmr.2003.18.5.876.
- Background: PubMed 15040821Rubin C, Recker R, Cullen D, Ryaby J, McCabe J, McLeod K. Prevention of postmenopausal bone loss by a low-magnitude, high-frequency mechanical stimuli: a clinical trial assessing compliance, efficacy, and safety. J Bone Miner Res. 2004 Mar;19(3):343-51. doi: 10.1359/JBMR.0301251. Epub 2003 Dec 22.
- Background: PubMed 15040822Verschueren SM, Roelants M, Delecluse C, Swinnen S, Vanderschueren D, Boonen S. Effect of 6-month whole body vibration training on hip density, muscle strength, and postural control in postmenopausal women: a randomized controlled pilot study. J Bone Miner Res. 2004 Mar;19(3):352-9. doi: 10.1359/JBMR.0301245. Epub 2003 Dec 22.
- Background: PubMed 15472009Stewart JM, Karman C, Montgomery LD, McLeod KJ. Plantar vibration improves leg fluid flow in perimenopausal women. Am J Physiol Regul Integr Comp Physiol. 2005 Mar;288(3):R623-9. doi: 10.1152/ajpregu.00513.2004. Epub 2004 Oct 7.
- Background: PubMed 25143898Mithal A, Bansal B, Kyer CS, Ebeling P. The Asia-Pacific Regional Audit-Epidemiology, Costs, and Burden of Osteoporosis in India 2013: A report of International Osteoporosis Foundation. Indian J Endocrinol Metab. 2014 Jul;18(4):449-54. doi: 10.4103/2230-8210.137485. No abstract available.
- Background: PubMed 27412619Morse LR, Nguyen N, Battaglino RA, Guarino AJ, Gagnon DR, Zafonte R, Garshick E. Wheelchair use and lipophilic statin medications may influence bone loss in chronic spinal cord injury: findings from the FRASCI-bone loss study. Osteoporos Int. 2016 Dec;27(12):3503-3511. doi: 10.1007/s00198-016-3678-4. Epub 2016 Jul 13.
- Background: PubMed 26576548Paleg G, Livingstone R. Systematic review and clinical recommendations for dosage of supported home-based standing programs for adults with stroke, spinal cord injury and other neurological conditions. BMC Musculoskelet Disord. 2015 Nov 17;16:358. doi: 10.1186/s12891-015-0813-x.
- Background: PubMed 26458973Menendez H, Ferrero C, Martin-Hernandez J, Figueroa A, Marin PJ, Herrero AJ. Acute effects of simultaneous electromyostimulation and vibration on leg blood flow in spinal cord injury. Spinal Cord. 2016 May;54(5):383-9. doi: 10.1038/sc.2015.181. Epub 2015 Oct 13.
- Background: PubMed 30035039Gao KL, Chan KM, Purves S, Tsang WWN. Reliability of dynamic sitting balance tests and their correlations with functional mobility for wheelchair users with chronic spinal cord injury. J Orthop Translat. 2014 Aug 7;3(1):44-49. doi: 10.1016/j.jot.2014.07.003. eCollection 2015 Jan.
- Background: PubMed 28167961Williams B, Allen B, Hu Z, True H, Cho J, Harris A, Fell N, Sartipi M. Real-Time Fall Risk Assessment Using Functional Reach Test. Int J Telemed Appl. 2017;2017:2042974. doi: 10.1155/2017/2042974. Epub 2017 Jan 10.
- Background: PubMed 20721676Ruhe A, Fejer R, Walker B. Center of pressure excursion as a measure of balance performance in patients with non-specific low back pain compared to healthy controls: a systematic review of the literature. Eur Spine J. 2011 Mar;20(3):358-68. doi: 10.1007/s00586-010-1543-2. Epub 2010 Aug 19.
- Background: PubMed 9817131Lam CL, Gandek B, Ren XS, Chan MS. Tests of scaling assumptions and construct validity of the Chinese (HK) version of the SF-36 Health Survey. J Clin Epidemiol. 1998 Nov;51(11):1139-47. doi: 10.1016/s0895-4356(98)00105-x.
- Individual participant dataSharing planned: No
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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.
Wing-hoi CHEUNG, Prof principal investigator
CUHK
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-magnitude High-frequency Vibration in people with Vibration Therapy and Wheelchair, run by Chinese University of Hong Kong at 3 sites in Hong Kong.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. 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 was stopped early (reason given: Discontinued due to COVID, community centres unable to provide services). Results are not available in the source record.
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?
Vertebral BMD (time frame: Half year). 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 NCT04180267, which also lists 22 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 14 Feb 2025.