13 completed, 4 terminated, 2 withdrawn. 8 Phase 1, 6 Phase 3, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 8 | Completed 7, Terminated 1 |
| Phase 3 | 6 | Completed 2, Terminated 2, Withdrawn 2 |
| Phase 2 | 5 | Completed 4, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076) odanacatib, placebo to odanacatib - Osteoporosis | Phase 3 | Terminated | Merck Sharp & Dohme LLC | 135 | 2013-03-14 | 2019-09-04 |
| A Study of Odanacatib When Administered to Adolescents and Young Adults Treated With Glucocorticoids (MK-0822-066) Odanacatib, Placebo - Osteoporosis | Phase 1 | Terminated | Merck Sharp & Dohme LLC | 19 | 2013-03-12 | 2018-08-28 |
| Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050) Odanacatib, Alendronate, Placebo (odanacatib) - Osteoporosis, Postmenopausal Osteoporosis | Phase 3 | Withdrawn | Merck Sharp & Dohme LLC | 2012-05-01 | 2015-08-27 | |
| Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070) MK-0822 - Hepatic Insufficiency | Phase 1 | Completed | Merck Sharp & Dohme LLC | 17 | 2012-02-23 | 2018-08-29 |
| Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067) MK-0822 - Renal Insufficiency | Phase 1 | Completed | Merck Sharp & Dohme LLC | 25 | 2012-01-17 | 2018-08-28 |
| A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053) Odanacatib, Placebo for Odanacatib, Vitamin D3 - Osteoporosis | Phase 3 | Completed | Merck Sharp & Dohme LLC | 294 | 2010-06-09 | 2018-08-28 |
| Safety and Tolerability of Odanacatib (0822-059) Odanacatib, Comparator: Placebo - Osteoporosis | Phase 1 | Completed | Merck Sharp & Dohme LLC | 44 | 2009-12-08 | 2018-08-28 |
| A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042) Odanacatib, Placebo, Vitamin D3 - Osteoporosis | Phase 2 | Completed | Merck Sharp & Dohme LLC | 246 | 2009-04-13 | 2018-08-28 |
| Study to Evaluate Efficacy of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Bone Micro-architecture and Overall Safety in Postmenopausal Women (MK-0822-031) Odanacatib, Placebo, Vitamin D3 - Osteoporosis | Phase 3 | Completed | Merck Sharp & Dohme LLC | 214 | 2008-10-02 | 2018-08-27 |
| A Study to Assess the Effects of MK0822 in Prolonging Time to First Bone Metastasis in Men With Castration-Resistant Prostate Cancer (0822-030) odanacatib, placebo (unspecified) - Prostate Cancer | Phase 3 | Withdrawn | Merck Sharp & Dohme LLC | 2008-09-01 | 2016-08-12 | |
| Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022) Odanacatib, Vitamin D3, Calcium carbonate - Osteoporosis Postmenopausal | Phase 2 | Completed | Merck Sharp & Dohme LLC | 287 | 2007-12-03 | 2018-08-27 |
| A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018) Odanacatib, Placebo for Odanacatib, Vitamin D3 - Postmenopausal Osteoporosis | Phase 3 | Terminated | Merck Sharp & Dohme LLC | 16071 | 2007-09-13 | 2024-06-11 |
| A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED) ZA, Odanacatib, Odanacatib matching placebo - Breast Cancer, Metastatic Bone Disease | Phase 2 | Completed | Merck Sharp & Dohme LLC | 43 | 2006-11-16 | 2018-08-16 |
| A 52-Week Study to Assess the Effects of MK0822 on Knee Osteoarthritis (MK-0822-011) MK0822 - Osteoarthritis | Phase 2 | Terminated | Merck Sharp & Dohme LLC | 2 | 2006-10-01 | 2015-11-02 |
| A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004) Odanacatib, Vitamin D3, Calcium Carbonate - Osteoporosis | Phase 2 | Completed | Merck Sharp & Dohme LLC | 399 | 2005-06-24 | 2018-01-24 |
| A Study to Assess the Effects of a Light Breakfast on the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) odanacatib, Comparator: Placebo - Osteoporosis | Phase 1 | Completed | Merck Sharp & Dohme LLC | 8 | 2004-11-01 | 2015-08-19 |
| A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED) odanacatib, Comparator: placebo to MK0822 - Osteoporosis | Phase 1 | Completed | Merck Sharp & Dohme LLC | 78 | 2004-11-01 | 2016-02-05 |
| Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002) odanacatib, Comparator: Placebo - Osteoporosis | Phase 1 | Completed | Merck Sharp & Dohme LLC | 62 | 2004-09-01 | 2015-08-19 |
| A Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) in Healthy Volunteers odanacatib, Comparator: odanacatib (Panel B), Comparator: odanacatib (Panel C) - Osteoporosis | Phase 1 | Completed | Merck Sharp & Dohme LLC | 24 | 2004-06-01 | 2015-08-19 |
Osteoporosis (12) · Osteoporosis, Postmenopausal (3) · Bone Diseases (1) · Breast Neoplasms (1) · Hepatic Insufficiency (1) · Osteoarthritis (1) · Prostatic Neoplasms (1) · Renal Insufficiency (1)
Chile (1) · Colombia (1) · Mexico (1) · Poland (1) · United States (1)
PMID 23013236, PMID 19874198, PMID 20740685, PMID 21147688, PMID 22777865, PMID 23337728, PMID 24064689, PMID 24276460, PMID 24898537, PMID 26879200, PMID 31676222, PMID 32119749, PMID 33200257, PMID 33724542, PMID 35711006
2008 (1)