Postmenopausal OsteoporosisYogANCT01501344
Open-label Study to Evaluate the Effect of MBP-80 on Bone Remodelling
A study testing 200 g yogurt with fortified calcium content and MBP 80 mg in people with Postmenopausal Osteoporosis, run by Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc. at 1 site in Canada.
Trial summary
This study will determine if daily oral intake of 200g of a marketed yogurt with fortified calcium content and a milk basic protein (MBP)80 mg benefits on bone cells activity in postmenopausal women. The efficacy of the product is measured by examining the variation of biochemical markers of bone turnover. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- 200 g yogurt with fortified calcium content and MBP 80 mg
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Aug 2011
- 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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Early postmenopausal women, aged 45-60 yrs old inclusive, with 1-5 yrs since last menses; naturally or surgically menopausal as a result of bilateral oophorectomy. Hysterectomized (≤ 5 yrs) women 50-60 yrs old.
- Lumbar Spine (L.S.;L1-L4) BMD > 0.772 g/cm2 (T-score of -2.5 on Hologic) and,
- Femoral Neck BMD > 0.572 g/cm2 (T-score of -2.5 on Hologic) and,
- Total Hip BMD > 0.637 g/cm2 (T-score of -2.5 on Hologic).
- Subjects must sign the Ethic Committee approved Informed Consent Form before any study procedure is initiated.
Who cannot join
- Any intake of calcium and vitamin D supplements including multivitamins, nutritional or dietary supplements of any kind containing calcium and vit D within 3 months prior to screening visit 1A.
- Daily dietary calcium intake > 600 mg as assessed by the Calcium Intake Calculator (Appendix E).
- Subjects who already suffer from osteoporosis on the basis of a low BMD T-score ≤ - 2.5 at any site or a personal history of fragility fracture after age 40.
- Any past or present use of:
- Bisphosphonate
- PTH or PTH derivatives, eg. teriparatide
Show all 38Show fewer
- Androgens, anabolic steroids or testosterone
- Tibolone
- Calcitriol
- Strontium ranelate
- Lithium, chronic warfarin or heparin use > 3 months, anticonvulsants (benzodiazepines are allowed), gonadotrophin-releasing hormone agonists, glitazones.
- Administration of any of the following treatments within the last 3 months prior to screening:
- Glucocorticosteroids (> 5 mg prednisone equivalent per day for > 10 days)
- Systemic hormone replacement therapy
- Selective estrogen receptor modulators (SERMs), eg, raloxifene
- Calcitonin
- Any unapproved hormone-like treatment in the opinion of the Principal Investigator (P.I.), i.e. phytoestrogens, isoflavones, etc.
- Antacids, H2 blockers, proton pump inhibitors for > 10 days
- Iron supplements for > 10 days
- Any condition or disease that may, according to the P.I., interfere with the evaluation of L.S. and Hip BMD; including but not limited to: advanced scoliosis or extensive lumbar fusion, less than 2 lumbar vertebrae (L1-L4) evaluable for DXA.
- Hyper or hypothyroidism: patients on stable dose of thyroid treatment with normal TSH will be allowed. Lab values for TSH must be normal or slightly abnormal, though clinically non significant in the opinion of the P.I.
- Current hyper or hypoparathyroidism, in the opinion of the P.I.
- Current hypocalcemia, in the opinion of the P.I.
- Vit D insufficiency (25-OH vitamin D level < 40 nmol/L)
- Significantly impaired renal function hereby defined as an estimated GFR ≤ 60 mL/min/ 1.73 m2 (4-variable MDRD equation).
- Rheumatoid arthritis.
- Paget's disease of bone.
- Any history of cancer within the past 5 years (except for basal cell carcinoma, dermal squamous cell carcinoma with 6 month remission and cervix carcinoma in situ).
- Any bone disease, i.e. osteomalacia or osteogenesis imperfecta.
- Chronic asthma, in the opinion of the P.I.
- Malabsorption syndrome (coeliac disease, inflammatory bowel disease, gastric bypass).
- Height, weight and girth which may preclude accurate DXA measurement; BMI outside ranges between 18.5 and 35 inclusive.
- Variation of more than 2 kg (gain or loss) within 2 months of the Screening.
- Presence of any vertebral fracture on the screening VFA (Vertebral Fracture Assessment) measured by DXA.
- Any previous or ongoing clinically significant illness that, in the opinion of the P.I., could prevent the patient from completing the study.
- Evidence of alcohol or substance abuse within the last 12 months that the P.I. believes would interfere with understanding or completing the study.
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
- Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-week, Open-label Study to Evaluate the Effect of MBP-80 (200g of Yogurt With Fortified Calcium Content and MBP 80 mg) on Bone Remodelling as Assessed by Bone Turnover Markers in Early Postmenopausal Women
This study will determine if daily oral intake of 200g of a marketed yogurt with fortified calcium content and a milk basic protein (MBP)80 mg benefits on bone cells activity in postmenopausal women. The efficacy of the product is measured by examining the variation of biochemical markers of bone turnover. MBP 80 is a particular protein contained in milk; it has been added to the yogurt provided for this study. The effects of MBP 80 on the quality of bone tissue have not yet been proven.
Read the detailed description
The morbidity and mortality associated with osteoporotic related fractures is devastating in terms of disability to an individual and cost to the global economy. As the world's population ages, this will present a major public health issue since a larger proportion of women remain undiagnosed and untreated even with the availability of therapies and calcium and vitamin D supplements. Consequently, it remains important to evaluate dairy products (milk, cheese, and yogurt) that can be safely provided as a supplement for bone health in addition to the current pharmacological treatments.
The rationale of this study is to assess the beneficial effect of a daily dietary supplement of MBP 80 mg in a yogurt matrix with fortified calcium content on bone remodelling in healthy early postmenopausal women with neither osteoporosis nor estrogens/progestin therapy.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- 200 g yogurt with fortified calcium content and MBP 80 mg
- Keywords
- osteoporosis, postmenopausal women, bone remodelling, bone turnover markers
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 g yogurt with fortified calcium content and MBP 80 mgDietary supplement
Also called Yoplait Asana TM
Intake of one container of vanilla or strawberry yogurt in the morning on a daily basis during 12 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Median percent change in levels of serum β CTX (sCTX), a bone resorption marker.
The primary efficacy variable, the median percent change from baseline (Day 0) in levels of serum β-CTX (sCTX) at week 12, will be compared to the corresponding median percent change from day minus 28 (Day - 28) in levels of serum β-CTX (sCTX) at Day 0 for each participant.
Measured: 12 weeks
Secondary outcomes (4)
Median percent change in levels of P1NP, a bone formation marker.
A secondary efficacy variable, the median percent change from baseline (Day 0) in levels of serum P1NP (sP1NP) at week 12, will be compared to the corresponding median percent change from day minus 28 (Day - 28) in levels of serum P1NP(sP1NP) at Day 0 for each participant.
Measured: 12 weeks
Median percent change in levels of serum β-CTX (sCTX), a bone resorption marker
A secondary efficacy variable, the median percent change from baseline (Day 0) in levels of serum β-CTX(sCTX) at week 4, will be compared to the corresponding median percent change from day minus 28 (Day - 28) in levels of serum β-CTX(sCTX) at Day 0 for each participant.
Measured: 4 weeks
Median percent change in levels of urinary NTX(uNTX), a bone resorption marker.
A secondary efficacy variable, the median percent change from baseline (Day 0) in levels of urinary NTX(uNTX) at weeks 4 and 12, will be compared to the corresponding median percent change from day minus 28 (Day - 28) in levels of urinary NTX(uNTX) at Day 0 for each participant.
Measured: weeks 4 and 12
Median percent change in levels of serum osteocalcin (sOC), a bone formation marker.
A secondary efficacy variable, the median percent change from baseline (Day 0) in levels of serum osteocalcin(sOC) at week 12, will be compared to the corresponding median percent change from day minus 28 (Day - 28) in levels of serum osteocalcin(sOC) at Day 0 for each participant.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aliments ULTIMA Foods Inc.
- Responsible party
- Principal investigator, Jacques Brown, Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.
- Investigators
- Jacques P Brown, M.D., Principal investigator, G.R.M.O. Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501344
- Sponsor's protocol ID
- 2010YogA80
- Other IDs
- MBP-80 and Bone Remodelling
- Acronym
- YogA
- Status last verified
- Dec 2011
- First submitted
- 27 Dec 2011
- Last updated
- 9 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Osteoporosis prevention, diagnosis, and therapy. NIH Consens Statement. 2000 Mar 27-29;17(1):1-45.
PubMed 11525451Eastell R. Treatment of postmenopausal osteoporosis. N Engl J Med. 1998 Mar 12;338(11):736-46. doi: 10.1056/NEJM199803123381107. No abstract available.
PubMed 9494151Raisz LG. Clinical practice. Screening for osteoporosis. N Engl J Med. 2005 Jul 14;353(2):164-71. doi: 10.1056/NEJMcp042092. No abstract available.
PubMed 16014886Dempster DW, Lindsay R. Pathogenesis of osteoporosis. Lancet. 1993 Mar 27;341(8848):797-801. doi: 10.1016/0140-6736(93)90570-7. No abstract available.
PubMed 8096008Cree MW, Juby AG, Carriere KC. Mortality and morbidity associated with osteoporosis drug treatment following hip fracture. Osteoporos Int. 2003 Sep;14(9):722-7. doi: 10.1007/s00198-003-1430-3. Epub 2003 Aug 7.
PubMed 12904833Kanis JA, Oden A, Johnell O, De Laet C, Jonsson B, Oglesby AK. The components of excess mortality after hip fracture. Bone. 2003 May;32(5):468-73. doi: 10.1016/s8756-3282(03)00061-9.
PubMed 12753862Takada Y, Aoe S, Kumegawa M. Whey protein stimulated the proliferation and differentiation of osteoblastic MC3T3-E1 cells. Biochem Biophys Res Commun. 1996 Jun 14;223(2):445-9. doi: 10.1006/bbrc.1996.0913.
PubMed 8670301Matsuoka Y, Serizawa A, Yoshioka T, Yamamura J, Morita Y, Kawakami H, Toba Y, Takada Y, Kumegawa M. Cystatin C in milk basic protein (MBP) and its inhibitory effect on bone resorption in vitro. Biosci Biotechnol Biochem. 2002 Dec;66(12):2531-6. doi: 10.1271/bbb.66.2531.
PubMed 12596844Olsson SL, Ek B, Bjork I. The affinity and kinetics of inhibition of cysteine proteinases by intact recombinant bovine cystatin C. Biochim Biophys Acta. 1999 Jun 15;1432(1):73-81. doi: 10.1016/s0167-4838(99)00090-4.
PubMed 10366730Inaoka T, Bilbe G, Ishibashi O, Tezuka K, Kumegawa M, Kokubo T. Molecular cloning of human cDNA for cathepsin K: novel cysteine proteinase predominantly expressed in bone. Biochem Biophys Res Commun. 1995 Jan 5;206(1):89-96. doi: 10.1006/bbrc.1995.1013.
PubMed 7818555Yamamura J, Morita Y, Takada Y, Kawakami H. The fragments of bovine high molecular weight kininogen promote osteoblast proliferation in vitro. J Biochem. 2006 Dec;140(6):825-30. doi: 10.1093/jb/mvj217. Epub 2006 Oct 28.
PubMed 17071946Uenishi K, Ishida H, Toba Y, Aoe S, Itabashi A, Takada Y. Milk basic protein increases bone mineral density and improves bone metabolism in healthy young women. Osteoporos Int. 2007 Mar;18(3):385-90. doi: 10.1007/s00198-006-0228-5. Epub 2006 Oct 18.
PubMed 17048062Toba Y, Takada Y. [Prevention of osteoporosis by foods and dietary supplements. "Mainichi Hone Kea MBP": A foods for specified health uses (FOSHU) product containing MBP that has an effect to increase bone density]. Clin Calcium. 2006 Oct;16(10):1701-5. Japanese.
PubMed 17012824Takada Y, Kobayashi N, Kato K, Matsuyama H, Yahiro M, Aoe S. Effects of whey protein on calcium and bone metabolism in ovariectomized rats. J Nutr Sci Vitaminol (Tokyo). 1997 Apr;43(2):199-210. doi: 10.3177/jnsv.43.199.
PubMed 9219093Toba Y, Takada Y, Yamamura J, Tanaka M, Matsuoka Y, Kawakami H, Itabashi A, Aoe S, Kumegawa M. Milk basic protein: a novel protective function of milk against osteoporosis. Bone. 2000 Sep;27(3):403-8. doi: 10.1016/s8756-3282(00)00332-x.
PubMed 10962352
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Open-label Study to Evaluate the Effect of MBP-80 (200g of Yogurt With Fortified Calcium Content and MBP 80 mg) on Bone Remodelling as Assessed by Bone Turnover Markers in Early Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01501344
- Acronym / sponsor ID
- YogA / 2010YogA80
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- osteoporosis, postmenopausal women, bone remodelling, bone turnover markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.Industry (pharma, biotech, devices)
- Collaborators
- Aliments ULTIMA Foods Inc.
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Dec 2011 (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.
This study will determine if daily oral intake of 200g of a marketed yogurt with fortified calcium content and a milk basic protein (MBP)80 mg benefits on bone cells activity in postmenopausal women. The efficacy of the product is measured by examining the variation of biochemical markers of bone turnover. MBP 80 is a particular protein contained in milk; it has been added to the yogurt provided for this study. The effects of MBP 80 on the quality of bone tissue have not yet been proven.
Detailed description
The morbidity and mortality associated with osteoporotic related fractures is devastating in terms of disability to an individual and cost to the global economy. As the world's population ages, this will present a major public health issue since a larger proportion of women remain undiagnosed and untreated even with the availability of therapies and calcium and vitamin D supplements. Consequently, it remains important to evaluate dairy products (milk, cheese, and yogurt) that can be safely provided as a supplement for bone health in addition to the current pharmacological treatments.
The rationale of this study is to assess the beneficial effect of a daily dietary supplement of MBP 80 mg in a yogurt matrix with fortified calcium content on bone remodelling in healthy early postmenopausal women with neither osteoporosis nor estrogens/progestin therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Early postmenopausal women, aged 45-60 yrs old inclusive, with 1-5 yrs since last menses; naturally or surgically menopausal as a result of bilateral oophorectomy. Hysterectomized (≤ 5 yrs) women 50-60 yrs old.
- Lumbar Spine (L.S.;L1-L4) BMD > 0.772 g/cm2 (T-score of -2.5 on Hologic) and,
- Femoral Neck BMD > 0.572 g/cm2 (T-score of -2.5 on Hologic) and,
- Total Hip BMD > 0.637 g/cm2 (T-score of -2.5 on Hologic).
- Subjects must sign the Ethic Committee approved Informed Consent Form before any study procedure is initiated.
Key exclusion criteria (38 listed)
- Any intake of calcium and vitamin D supplements including multivitamins, nutritional or dietary supplements of any kind containing calcium and vit D within 3 months prior to screening visit 1A.
- Daily dietary calcium intake > 600 mg as assessed by the Calcium Intake Calculator (Appendix E).
- Subjects who already suffer from osteoporosis on the basis of a low BMD T-score ≤ - 2.5 at any site or a personal history of fragility fracture after age 40.
- Any past or present use of:
- Bisphosphonate
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 |
|---|---|---|
| 200 g yogurt with fortified calcium content and MBP 80 mgAlso: Yoplait Asana TMIntake of one container of vanilla or strawberry yogurt in the morning on a daily basis during 12 weeks. | Dietary supplement | – |
Primary outcome
Median percent change in levels of serum β CTX (sCTX), a bone resorption marker.
Time frame: 12 weeks
The primary efficacy variable, the median percent change from baseline (Day 0) in levels of serum β-CTX (sCTX) at week 12, will be compared to the corresponding median percent change from day minus 28 (Day - 28) in levels of serum β-CTX (sCTX) at Day 0 for each participant.
4 secondary outcomes
Median percent change in levels of P1NP, a bone formation marker.
Time frame: 12 weeks
Median percent change in levels of serum β-CTX (sCTX), a bone resorption marker
Time frame: 4 weeks
Median percent change in levels of urinary NTX(uNTX), a bone resorption marker.
Time frame: weeks 4 and 12
Median percent change in levels of serum osteocalcin (sOC), a bone formation marker.
Time frame: 12 weeks
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 9 Jan 2012.
- Background: PubMed 11525451Osteoporosis prevention, diagnosis, and therapy. NIH Consens Statement. 2000 Mar 27-29;17(1):1-45.
- Background: PubMed 9494151Eastell R. Treatment of postmenopausal osteoporosis. N Engl J Med. 1998 Mar 12;338(11):736-46. doi: 10.1056/NEJM199803123381107. No abstract available.
- Background: PubMed 16014886Raisz LG. Clinical practice. Screening for osteoporosis. N Engl J Med. 2005 Jul 14;353(2):164-71. doi: 10.1056/NEJMcp042092. No abstract available.
- Background: PubMed 8096008Dempster DW, Lindsay R. Pathogenesis of osteoporosis. Lancet. 1993 Mar 27;341(8848):797-801. doi: 10.1016/0140-6736(93)90570-7. No abstract available.
- Background: PubMed 12904833Cree MW, Juby AG, Carriere KC. Mortality and morbidity associated with osteoporosis drug treatment following hip fracture. Osteoporos Int. 2003 Sep;14(9):722-7. doi: 10.1007/s00198-003-1430-3. Epub 2003 Aug 7.
- Background: PubMed 12753862Kanis JA, Oden A, Johnell O, De Laet C, Jonsson B, Oglesby AK. The components of excess mortality after hip fracture. Bone. 2003 May;32(5):468-73. doi: 10.1016/s8756-3282(03)00061-9.
- Background: PubMed 8670301Takada Y, Aoe S, Kumegawa M. Whey protein stimulated the proliferation and differentiation of osteoblastic MC3T3-E1 cells. Biochem Biophys Res Commun. 1996 Jun 14;223(2):445-9. doi: 10.1006/bbrc.1996.0913.
- Background: PubMed 12596844Matsuoka Y, Serizawa A, Yoshioka T, Yamamura J, Morita Y, Kawakami H, Toba Y, Takada Y, Kumegawa M. Cystatin C in milk basic protein (MBP) and its inhibitory effect on bone resorption in vitro. Biosci Biotechnol Biochem. 2002 Dec;66(12):2531-6. doi: 10.1271/bbb.66.2531.
- Background: PubMed 10366730Olsson SL, Ek B, Bjork I. The affinity and kinetics of inhibition of cysteine proteinases by intact recombinant bovine cystatin C. Biochim Biophys Acta. 1999 Jun 15;1432(1):73-81. doi: 10.1016/s0167-4838(99)00090-4.
- Background: PubMed 7818555Inaoka T, Bilbe G, Ishibashi O, Tezuka K, Kumegawa M, Kokubo T. Molecular cloning of human cDNA for cathepsin K: novel cysteine proteinase predominantly expressed in bone. Biochem Biophys Res Commun. 1995 Jan 5;206(1):89-96. doi: 10.1006/bbrc.1995.1013.
- Background: PubMed 17071946Yamamura J, Morita Y, Takada Y, Kawakami H. The fragments of bovine high molecular weight kininogen promote osteoblast proliferation in vitro. J Biochem. 2006 Dec;140(6):825-30. doi: 10.1093/jb/mvj217. Epub 2006 Oct 28.
- Background: PubMed 17048062Uenishi K, Ishida H, Toba Y, Aoe S, Itabashi A, Takada Y. Milk basic protein increases bone mineral density and improves bone metabolism in healthy young women. Osteoporos Int. 2007 Mar;18(3):385-90. doi: 10.1007/s00198-006-0228-5. Epub 2006 Oct 18.
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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.
Jacques P Brown, M.D. principal investigator
G.R.M.O. Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 200 g yogurt with fortified calcium content and MBP 80 mg in people with Postmenopausal Osteoporosis, run by Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc. at 1 site in Canada.
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 5 inclusion and 38 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 9 Jan 2012. 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 Canada. 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?
Median percent change in levels of serum β CTX (sCTX), a bone resorption marker. (time frame: 12 weeks). 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 NCT01501344, which also lists 31 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 9 Jan 2012.