OsteoporosisPhase 3NCT01552122
Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)
A Phase 3 study testing Odanacatib, Alendronate and Cholecalciferol (Vitamin D3) in people with Osteoporosis and Postmenopausal Osteoporosis, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal Osteoporosis
- What is being tested?
- Odanacatib, Alendronate and Cholecalciferol (Vitamin D3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Feb 2015
- Phase
- Phase 3
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In good general health, and postmenopausal for at least 5 years or more
- Diagnosed with postmenopausal osteoporosis
- Currently taking alendronate for at least 3 years or more for the treatment of osteoporosis
- One hip free of orthopedic hardware (ie, total hip device, hip pin); anatomy is suitable to undergo a dual-emission X-ray absorptiometry (DXA) scan (ie, bone mineral density scan)
- Agrees to not to use any other medications for the treatment of osteoporosis except those provided to the participant during the study
Who cannot join
- Evidence of metabolic bone disorder
- History of malignancy (cancer) for 5 years or less
- Active thyroid disease that cannot be managed with medication
- Severe renal insufficiency (kidney disease), myocardial infarction, unstable angina, stroke or revascularization, untreated malabsorption syndrome, and/or osteonecrosis of the jaw, or anticipates undergoing a major dental procedure (e.g. dental extraction or implantation)
- Use, misuse, abuse, and/or addiction of illicit drugs and/or recent history
- (within the last year) of drug or alcohol abuse or dependence
- Use of estrogen with or without progestin and/or raloxifene (ie, Evista®) or tamoxifen (ie, Nolvadex®, Tamofen®)
- Use of any oral bisphosphonate therapy other than alendronate; intravenous bisphosphonates (zoledronate, ibandronate, pamidronate); any form of calcitonin other than intranasal; anabolic steroids; and/or Strontium-containing products (ie, Osteovalin™)
About this study
Official title: A Phase III Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density, Tolerability, and Safety in the Treatment of Postmenopausal Women With Osteoporosis Previously Treated With Alendronate
This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate.
- Conditions
- Osteoporosis, Postmenopausal Osteoporosis
- Being tested
- Odanacatib, Alendronate, Placebo (odanacatib), Cholecalciferol (Vitamin D3), Calcium carbonate
- Medical subject headings
- Osteoporosis, Osteoporosis, Postmenopausal
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 compressed tablet will be administered orally, once-a-week, for 24 months
AlendronateDrug
Also called Alendronate Sodium, Fosamax
Alendronate 70 mg compressed tablets will be administered orally, once-a-week, for 24 months; and a reduced dose of 35 mg will be administered in the same fashion to a subset of women, Japanese participants only, for the same 24-month duration.
Placebo (odanacatib)Other
One compressed tablet administered orally, once-a-week, for 24 months.
Cholecalciferol (Vitamin D3)Dietary supplement
Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.
Calcium carbonateDietary supplement
Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.
Placebo (alendronate)Other
One compressed tablet administered orally, once-a-week, for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Odanacatib | Experimental | Not described Receives: Drug: Odanacatib; Dietary Supplement: Cholecalciferol (Vitamin D3); Dietary Supplement: Calcium carbonate; Other: Placebo (alendronate) |
| Alendronate | Active comparator | Not described Receives: Drug: Alendronate; Other: Placebo (odanacatib); Dietary Supplement: Cholecalciferol (Vitamin D3); Dietary Supplement: Calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck
Measured: Baseline and Month 24
Secondary outcomes (1)
Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter
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 posted13 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552122
- Sponsor's protocol ID
- 0822-050
- Status last verified
- Aug 2015
- First submitted
- 9 Mar 2012
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density, Tolerability, and Safety in the Treatment of Postmenopausal Women With Osteoporosis Previously Treated With Alendronate
- ClinicalTrials.gov ID
- NCT01552122
- Acronym / sponsor ID
- 0822-050
- Conditions
- Osteoporosis, Postmenopausal Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 13 Mar 2012 (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 evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Odanacatib | Experimental | Drug: Odanacatib, Dietary Supplement: Cholecalciferol (Vitamin D3), Dietary Supplement: Calcium carbonate, Other: Placebo (alendronate) |
| Alendronate | Active comparator | Drug: Alendronate, Other: Placebo (odanacatib), Dietary Supplement: Cholecalciferol (Vitamin D3), Dietary Supplement: Calcium carbonate |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In good general health, and postmenopausal for at least 5 years or more
- Diagnosed with postmenopausal osteoporosis
- Currently taking alendronate for at least 3 years or more for the treatment of osteoporosis
- One hip free of orthopedic hardware (ie, total hip device, hip pin); anatomy is suitable to undergo a dual-emission X-ray absorptiometry (DXA) scan (ie, bone mineral density scan)
- Agrees to not to use any other medications for the treatment of osteoporosis except those provided to the participant during the study
Key exclusion criteria (8 listed)
- Evidence of metabolic bone disorder
- History of malignancy (cancer) for 5 years or less
- Active thyroid disease that cannot be managed with medication
- Severe renal insufficiency (kidney disease), myocardial infarction, unstable angina, stroke or revascularization, untreated malabsorption syndrome, and/or osteonecrosis of the jaw, or anticipates undergoing a major dental procedure (e.g. dental extraction or implantation)
- Use, misuse, abuse, and/or addiction of illicit drugs and/or recent history
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 compressed tablet will be administered orally, once-a-week, for 24 months | Drug | Odanacatib |
| AlendronateAlso: Alendronate Sodium, FosamaxAlendronate 70 mg compressed tablets will be administered orally, once-a-week, for 24 months; and a reduced dose of 35 mg will be administered in the same fashion to a subset of women, Japanese participants only, for the same 24-month duration. | Drug | Alendronate |
| Placebo (odanacatib)One compressed tablet administered orally, once-a-week, for 24 months. | Other | Alendronate |
| Cholecalciferol (Vitamin D3)Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months. | Dietary supplement | Alendronate, Odanacatib |
| Calcium carbonateDietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg. | Dietary supplement | Alendronate, Odanacatib |
| Placebo (alendronate)One compressed tablet administered orally, once-a-week, for 24 months. | Other | Odanacatib |
Primary outcome
Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck
Time frame: Baseline and Month 24
1 secondary outcome
Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter
Time frame: Baseline and Month 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Odanacatib, Alendronate and Cholecalciferol (Vitamin D3) in people with Osteoporosis and Postmenopausal 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 27 Aug 2015. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 in Bone Mineral Density (BMD) of the Femoral Neck (time frame: Baseline and Month 24). 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 27 Aug 2015.