OsteoporosisPhase 3NCT01803607
Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076)
A Phase 3 study testing odanacatib in people with Osteoporosis, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to assess to what extent sequential treatment with odanacatib results in incremental gains in bone mineral density (BMD) over time in female participants who have received at least 3 years of bisphosphonate therapy. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- odanacatib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2013to 11 Nov 2014
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal for ≥5 years (defined as no menses for at least 5 years or at least 5 years post bilateral oophorectomy).
- Prior or current treatment with oral bisphosphonate therapy (i.e., alendronate, risedronate, ibandronate) for postmenopausal osteoporosis for ≥3 years.
- BMD T-score at any hip site (femoral neck, trochanter, or total hip) ≤-2.5 and >-3.5 as assessed by dual-energy X-ray absorptiometry (DXA) without a history of a prior fragility fracture. For participants with a history of a prior fragility fracture (except hip fracture), BMD T-score can be ≤-1.5 and >-3.5 at any hip site.
- Serum 25-hydroxyvitamin D level of ≥20 and ≤60 ng/mL within 90 days of the time of randomization.
Who cannot join
- Evidence of a metabolic bone disorder other than osteopenia or osteoporosis
- History or current evidence of hip fracture.
- History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Active parathyroid disease. Participant with a documented history of parathyroid disease can be considered for inclusion if she has normal parathyroid hormone (PTH) at screening.
- History of thyroid disease not adequately controlled by medication.
- Current treatment with anti-seizure medication, with indices of calcium metabolism not within normal limits.
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- Prior treatment with strontium-containing products; intravenous bisphosphonates; cathepsin K inhibitors; RANK ligand inhibitors; fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks.
- Use of following medications within the 6 months prior to the screening visit: activated vitamin D; estrogen, with or without progestin, at a dose high enough to have systemic effects; raloxifene or other selective estrogen receptor modulator (SERM), tibolone or any aromatase inhibitor; sub-cutaneous calcitonin (Note: use of intranasal calcitonin is allowed at any time); anabolic steroid; PTH (1-34 or 1-84); growth hormone; systemic glucocorticoids (≥5 mg/day of prednisone or equivalent) for more than 2 weeks; cyclosporine for more than 2 weeks.
- Concurrent use of cancer chemotherapy or heparin; protease inhibitors for human immunodeficiency virus (HIV) treatment; and vitamin A (excluding beta carotene) >10,000 IU daily, unless willing to discontinue this dose during the study.
- Current treatment with cytochrome P450 3A4 (CYP3A4) inducers or treatment with CYP3A4 inducer within 4 weeks of screening.
About this study
Official title: A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate
The purpose of this study is to assess to what extent sequential treatment with odanacatib results in incremental gains in bone mineral density (BMD) over time in female participants who have received at least 3 years of bisphosphonate therapy. It was hypothesized that odanacatib treatment would increase femoral neck BMD relative to placebo after 24 months.
- Conditions
- Osteoporosis
- Being tested
- odanacatib, placebo to odanacatib
- 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
odanacatib 50 mg oral tablet
placebo to odanacatibOther
dose-matched placebo to odanacatib, oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Odanacatib 50 mg | Experimental | Participants will receive odanacatib 50 mg once weekly for 24 months. Additionally, all participants will receive weekly supplementation with 5600 international units (IU) of Vitamin D3 and, if required, will be provided with an open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. Receives: Drug: odanacatib |
| Placebo | Placebo comparator | Participants will receive dose-matched placebo to odanacatib once weekly for 24 months. Additionally, all participants will receive weekly supplementation with 5600 IU Vitamin D3 and, if required, will be provided with an open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. Receives: Other: placebo to odanacatib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to Month 12 in Femoral BMD
Dual-energy X-ray absorptiometry (DXA) was used to determine the change from baseline in femoral neck BMD at Month 12.
Measured: Baseline and Month 12
Secondary outcomes (7)
Percent Change From Baseline to Month 24 in Femoral Neck BMD: Within-Group Comparison of Odanacatib
DXA was used to determine the within-group change from baseline in femoral neck BMD at Month 24.
Measured: Baseline and Month 24
Percent Change From Baseline to Month 12 in Trochanter, Total Hip, and Lumbar Spine BMD
DXA was used to determine the change from baseline in trochanter, total hip, and lumbar spine BMD at Month 12.
Measured: Baseline and Month 12
Change From Baseline in Serum C-telopeptides of Type 1 Collagen (s-CTx)
s-CTx is a biochemical marker of bone resorption. At baseline and Month 12, s-CTx was measured and expressed in ng/mL and results are expressed as percentage change from baseline.
Measured: Baseline and Month 12
Change From Baseline in Urine C-telopeptides of Type I Collagen (u-CTx)
u-CTx is a biochemical marker of bone resorption. At baseline and Month 12, u-CTx was measured and expressed in ug/mL and results are expressed as percentage change from baseline.
Measured: Baseline and Month 12
Change From Baseline in Urine N-telopeptides of Type 1 Collagen Corrected for Creatinine (u-NTx/Cr)
The u-NTx/Cr ratio is a biochemical marker of bone resorption. u-NTx/Cr was measured at baseline and Month 12 and expressed in nM:mM and results are expressed as percentage change from baseline.
Measured: Baseline and Month 12
Change From Baseline in Serum Bone Specific Alkaline Phosphatase (s-BSAP)
s-BSAP is a biochemical marker of bone resorption. s-BSAP was measured and expressed in ng/mL at Baseline and Month 12, and results are shown as percentage change from baseline.
Measured: Baseline and Month 12
Change From Baseline in Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)
s-P1NP is a biochemical marker of bone resorption. s-P1NP was measured and expressed as ng/mL at Baseline and Month 12, and results are expressed as percentage change from baseline.
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study start14 Mar 2013
- Primary completion11 Nov 2014
- Study completion11 Nov 2014
Why it stopped: Study halted prematurely due to low enrollment.
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.
- 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
- 135 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
- NCT01803607
- Sponsor's protocol ID
- 0822-076
- Status last verified
- Aug 2019
- First submitted
- 28 Feb 2013
- Last updated
- 4 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate
- ClinicalTrials.gov ID
- NCT01803607
- Acronym / sponsor ID
- 0822-076
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely due to low enrollment.
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2013 (actual)
- Primary completion
- 11 Nov 2014 (actual)
- Study completion
- 11 Nov 2014 (actual)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Posted 22 May 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 assess to what extent sequential treatment with odanacatib results in incremental gains in bone mineral density (BMD) over time in female participants who have received at least 3 years of bisphosphonate therapy. It was hypothesized that odanacatib treatment would increase femoral neck BMD relative to placebo after 24 months.
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 | Experimental | Drug: odanacatibParticipants will receive odanacatib 50 mg once weekly for 24 months. Additionally, all participants will receive weekly supplementation with 5600 international units (IU) of Vitamin D3 and, if required, will be provided with an open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. |
| Placebo | Placebo comparator | Other: placebo to odanacatibParticipants will receive dose-matched placebo to odanacatib once weekly for 24 months. Additionally, all participants will receive weekly supplementation with 5600 IU Vitamin D3 and, if required, will be provided with an open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal for ≥5 years (defined as no menses for at least 5 years or at least 5 years post bilateral oophorectomy).
- Prior or current treatment with oral bisphosphonate therapy (i.e., alendronate, risedronate, ibandronate) for postmenopausal osteoporosis for ≥3 years.
- BMD T-score at any hip site (femoral neck, trochanter, or total hip) ≤-2.5 and >-3.5 as assessed by dual-energy X-ray absorptiometry (DXA) without a history of a prior fragility fracture. For participants with a history of a prior fragility fracture (except hip fracture), BMD T-score can be ≤-1.5 and >-3.5 at any hip site.
- Serum 25-hydroxyvitamin D level of ≥20 and ≤60 ng/mL within 90 days of the time of randomization.
Key exclusion criteria (10 listed)
- Evidence of a metabolic bone disorder other than osteopenia or osteoporosis
- History or current evidence of hip fracture.
- History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Active parathyroid disease. Participant with a documented history of parathyroid disease can be considered for inclusion if she has normal parathyroid hormone (PTH) at screening.
- History of thyroid disease not adequately controlled by medication.
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-0822odanacatib 50 mg oral tablet | Drug | Odanacatib 50 mg |
| placebo to odanacatibdose-matched placebo to odanacatib, oral tablet | Other | Placebo |
Primary outcome
Percent Change From Baseline to Month 12 in Femoral BMD
Time frame: Baseline and Month 12
Dual-energy X-ray absorptiometry (DXA) was used to determine the change from baseline in femoral neck BMD at Month 12.
7 secondary outcomes
Percent Change From Baseline to Month 24 in Femoral Neck BMD: Within-Group Comparison of Odanacatib
Time frame: Baseline and Month 24
Percent Change From Baseline to Month 12 in Trochanter, Total Hip, and Lumbar Spine BMD
Time frame: Baseline and Month 12
Change From Baseline in Serum C-telopeptides of Type 1 Collagen (s-CTx)
Time frame: Baseline and Month 12
Change From Baseline in Urine C-telopeptides of Type I Collagen (u-CTx)
Time frame: Baseline and Month 12
Change From Baseline in Urine N-telopeptides of Type 1 Collagen Corrected for Creatinine (u-NTx/Cr)
Time frame: Baseline and Month 12
Change From Baseline in Serum Bone Specific Alkaline Phosphatase (s-BSAP)
Time frame: Baseline and Month 12
Change From Baseline in Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)
Time frame: Baseline and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/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 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 10 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 4 Sep 2019. 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 22 May 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?
Percent Change From Baseline to Month 12 in Femoral BMD (time frame: Baseline and Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2019.