Post-Menopausal OsteoporosisPhase 2NCT00533650
Proof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005)
A Phase 2 study testing MK0429 in people with Post-Menopausal Osteoporosis, run by Merck Sharp & Dohme LLC.
Trial summary
A study to asses the safety and efficacy of MK0429 in postmenopausal women with osteoporosis. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Post-Menopausal Osteoporosis
- What is being tested?
- MK0429
- How many people
- 227 participants
- Where
- No sites listed yet
- Study dates
- Dec 2000to Oct 2002
- Phase
- Phase 2
- 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 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Person is a women with osteoporosis who is unwilling or unable to take other treatments for osteoporosis
Who cannot join
- Person has had a previous fracture
- Person has rheumatoid arthritis. Person has has certain types of cancer
- Person has donated blood or has been in another investigational study within the last 4 weeks
About this study
A study to asses the safety and efficacy of MK0429 in postmenopausal women with osteoporosis.
- Conditions
- Post-Menopausal Osteoporosis
- Being tested
- MK0429
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0429Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startDec 2000
- Primary completionOct 2002
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Menopausal 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533650
- Sponsor's protocol ID
- 0429-005
- Other IDs
- 2007_620
- Status last verified
- May 2016
- First submitted
- 19 Sep 2007
- Last updated
- 29 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005)
- ClinicalTrials.gov ID
- NCT00533650
- Acronym / sponsor ID
- 0429-005
- Conditions
- Post-Menopausal Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Oct 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 21 Sep 2007 (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.
A study to asses the safety and efficacy of MK0429 in postmenopausal women with osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Person is a women with osteoporosis who is unwilling or unable to take other treatments for osteoporosis
Key exclusion criteria (3 listed)
- Person has had a previous fracture
- Person has rheumatoid arthritis. Person has has certain types of cancer
- Person has donated blood or has been in another investigational study within the last 4 weeks
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 |
|---|---|---|
| MK0429 | Drug | – |
Primary outcome
Not reported in the source record.
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 29 Jul 2016.
Related trials for Post-Menopausal Osteoporosis
Recruiting
Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis
Post Menopausal Osteoporosis
Not yet recruitingPhase 4
Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD
Osteoporosis in Post-menopausal Women
Active, not recruitingPhase 1
Intravenous Infusion of Human Mesenchymal Stem Cells (HMM910 ) in Postmenopausal Women With Osteoporosis at High Risk of Fracture
Osteoporosis in Post-menopausal Women, Osteoporosis
Not yet recruiting
Bone Health in Postmenopausal Women: The Effect of Exercise With or Without Medication for Osteoporosis
Osteoporosis in Post-menopausal Women
Recruiting
EFFECT OF CIRCUIT TRAINING ON BONE MINERAL DENSITY IN POST MENOPAUSAL PERIOD
Post Menopausal, Osteoporosis
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 Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK0429 in people with Post-Menopausal 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 1 inclusion and 3 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 29 Jul 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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.
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 29 Jul 2016; AzTrials last refreshed its copy on 30 Oct 2026.