OsteoporosisPhase 3NCT01120600
A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)
A Phase 3 study testing Odanacatib, Vitamin D3 and Calcium carbonate in people with Osteoporosis, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants. Read more about this study
- Who is it for?
- Ages 40 to 95 years, men only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Odanacatib, Vitamin D3 and Calcium carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- No sites listed yet
- Study dates
- 9 Jun 2010to 22 Jul 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a male between 40 and 95 years of age
- Has osteoporosis
- Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar spine and and hip
- Is ambulatory
Who cannot join
- Is currently on oral bisphosphonates or other treatment for osteoporosis
- Had previous hip fragility fracture and is a candidate for standard of care therapy
- Has had a fragility fracture (vertebral or non-vertebral fractures indicating reduced bone strength) within 12 months
- Has had more then one previous vertebral fracture
- Has been diagnosed with metabolic bone disorder other than osteoporosis
- Is Vitamin D deficient
Show all 13Show fewer
- Has a history of renal stones
- Has active parathyroid disease
- Has history of thyroid disease not well controlled by medication
- Is diagnosed with secondary osteoporosis
- Has a daily calcium intake of <1,200 mg and is unwilling to take study prescribed supplements or increase dietary intake, such that his daily calcium intake is at least 1200 mg
- Has a history of malignancy ≤5 years prior to signing informed consent
- Has been diagnosed with hypogonadism due to causes that affect multiple organ and body systems
About this study
Official title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) in the Treatment of Men With Osteoporosis Treated With Vitamin D and Calcium
The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.
Read the detailed description
The original study was divided into two parts, with the primary analysis of endpoints to occur at 24 months and participants will then remain in the study for an additional 12 months (Part 2). Amendment 1 of the protocol removed the additional 12 month period and the Month 36 BMD analysis was deleted.
- Conditions
- Osteoporosis
- Being tested
- Odanacatib, Placebo for Odanacatib, Vitamin D3, Calcium carbonate
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OdanacatibDrug
Also called MK-0822
One 50 mg tablet once weekly
Placebo for OdanacatibDrug
One 50 mg tablet once weekly
Vitamin D3Dietary supplement
5600 IU of open-label Vitamin D3 once weekly
Calcium carbonateDietary supplement
Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg
| Study group | Role | What they receive |
|---|---|---|
| Odanacatib 50 mg once weekly | Experimental | Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg. Receives: Drug: Odanacatib; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate |
| Placebo once weekly | Placebo comparator | Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg. Receives: Drug: Placebo for Odanacatib; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24
Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.
Measured: Baseline and Month 24
Number of Participants Who Experienced an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Measured: Up to 24 months (plus 14 days) after first dose of study drug
Number of Participants Who Discontinued Treatment Due to an AE
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Measured: Up to 24 months after first dose of study drug
Secondary outcomes (7)
Percentage Change From Baseline in Total Hip BMD at Month 24
Total hip BMD was assessed by DXA at Baseline and at Month 24.
Measured: Baseline and Month 24
Percentage Change From Baseline in Femoral Neck BMD at Month 24
Femoral Neck BMD was assessed by DXA at Baseline and at Month 24.
Measured: Baseline and Month 24
Percentage Change From Baseline in Trochanter BMD at Month 24
Trochanter BMD was assessed by DXA at Baseline and at Month 24.
Measured: Baseline and Month 24
Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24
Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Month 24.
Measured: Baseline and Month 24
Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24
Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Month 24.
Measured: Baseline and Month 24
Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24
Serum samples were collected to evaluate biochemical markers for s-BSAP, which were measured at Baseline and at Month 24.
Measured: Baseline and Month 24
Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24
Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24.
Measured: Baseline and Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study start9 Jun 2010
- Primary completion22 Jul 2013
- Study completion22 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120600
- Sponsor's protocol ID
- 0822-053
- Other IDs
- 2010_532
- Status last verified
- Jul 2018
- First submitted
- 7 May 2010
- Last updated
- 28 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Binkley N, Orwoll E, Chapurlat R, Langdahl BL, Scott BB, Giezek H, Santora AC. Randomized, controlled trial to assess the safety and efficacy of odanacatib in the treatment of men with osteoporosis. Osteoporos Int. 2021 Jan;32(1):173-184. doi: 10.1007/s00198-020-05701-9. Epub 2020 Nov 17.
PubMed 33200257
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) in the Treatment of Men With Osteoporosis Treated With Vitamin D and Calcium
- ClinicalTrials.gov ID
- NCT01120600
- Acronym / sponsor ID
- 0822-053
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2010 (actual)
- Primary completion
- 22 Jul 2013 (actual)
- Study completion
- 22 Jul 2013 (actual)
- First posted
- 11 May 2010 (estimated)
- Results
- Posted 6 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.
Detailed description
The original study was divided into two parts, with the primary analysis of endpoints to occur at 24 months and participants will then remain in the study for an additional 12 months (Part 2). Amendment 1 of the protocol removed the additional 12 month period and the Month 36 BMD analysis was deleted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Odanacatib 50 mg once weekly | Experimental | Drug: Odanacatib, Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium carbonateParticipants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg. |
| Placebo once weekly | Placebo comparator | Drug: Placebo for Odanacatib, Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium carbonateParticipants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg. |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is a male between 40 and 95 years of age
- Has osteoporosis
- Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar spine and and hip
- Is ambulatory
Key exclusion criteria (13 listed)
- Is currently on oral bisphosphonates or other treatment for osteoporosis
- Had previous hip fragility fracture and is a candidate for standard of care therapy
- Has had a fragility fracture (vertebral or non-vertebral fractures indicating reduced bone strength) within 12 months
- Has had more then one previous vertebral fracture
- Has been diagnosed with metabolic bone disorder other than osteoporosis
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 |
|---|---|---|
| OdanacatibAlso: MK-0822One 50 mg tablet once weekly | Drug | Odanacatib 50 mg once weekly |
| Placebo for OdanacatibOne 50 mg tablet once weekly | Drug | Placebo once weekly |
| Vitamin D35600 IU of open-label Vitamin D3 once weekly | Dietary supplement | Odanacatib 50 mg once weekly, Placebo once weekly |
| Calcium carbonateSufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg | Dietary supplement | Odanacatib 50 mg once weekly, Placebo once weekly |
Primary outcome
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24
Time frame: Baseline and Month 24
Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to 24 months (plus 14 days) after first dose of study drug
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Number of Participants Who Discontinued Treatment Due to an AE
Time frame: Up to 24 months after first dose of study drug
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
7 secondary outcomes
Percentage Change From Baseline in Total Hip BMD at Month 24
Time frame: Baseline and Month 24
Percentage Change From Baseline in Femoral Neck BMD at Month 24
Time frame: Baseline and Month 24
Percentage Change From Baseline in Trochanter BMD at Month 24
Time frame: Baseline and Month 24
Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24
Time frame: Baseline and Month 24
Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24
Time frame: Baseline and Month 24
Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24
Time frame: Baseline and Month 24
Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24
Time frame: Baseline and Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33200257Binkley N, Orwoll E, Chapurlat R, Langdahl BL, Scott BB, Giezek H, Santora AC. Randomized, controlled trial to assess the safety and efficacy of odanacatib in the treatment of men with osteoporosis. Osteoporos Int. 2021 Jan;32(1):173-184. doi: 10.1007/s00198-020-05701-9. Epub 2020 Nov 17.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Odanacatib, Vitamin D3 and Calcium carbonate in people with Osteoporosis, run by Merck Sharp & Dohme LLC.
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 4 inclusion and 13 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 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24 (time frame: Baseline and Month 24). The study lists 3 primary outcomes in all. 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 NCT01120600, which also lists 1 linked publication.
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 28 Aug 2018.