A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (0822-042)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00885170
First received: April 20, 2009
Last updated: March 13, 2014
Last verified: March 2014

April 20, 2009
March 13, 2014
April 2009
September 2011   (final data collection date for primary outcome measure)
Percent change in BMD from baseline at the femoral neck site assessed by DXA [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00885170 on ClinicalTrials.gov Archive Site
  • 1) Percent change in BMD from baseline at the trochanter, total hip, lumbar spine, total body and forearm sites assessed by DXA 2) Evaluate the effect of treatment on biochemical markers of bone turnover and indices of calcium and mineral homeostasis [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Evaluate the effect of treatment on biochemical markers of bone turnover and indices of calcium and mineral homeostasis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Percent change in BMD from baseline at the trochanter, total hip, lumbar spine, total body and forearm sites assessed by DXA [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Evaluate the effect of treatment on biochemical markers of bone turnover and indices of calcium and mineral homeostasis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (0822-042)(COMPLETED)
A Phase IIa Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Odanacatib (MK0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With Alendronate

The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoporosis
  • Drug: odanacatib
    odanacatib 50 mg tablets once weekly for 24 months
  • Drug: Comparator: Placebo
    Placebo to odanacatib 50 mg tablets once weekly for 24 months
  • Dietary Supplement: Vitamin D3
    Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months
  • Dietary Supplement: Calcium
    Patients will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
  • Experimental: 1
    odanacatib
    Interventions:
    • Drug: odanacatib
    • Dietary Supplement: Vitamin D3
    • Dietary Supplement: Calcium
  • Placebo Comparator: 2
    Placebo
    Interventions:
    • Drug: Comparator: Placebo
    • Dietary Supplement: Vitamin D3
    • Dietary Supplement: Calcium
Bonnick S, De Villiers T, Odio A, Palacios S, Chapurlat R, Dasilva C, Scott BB, Le Bailly De Tilleghem C, Leung AT, Gurner D. Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate: a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2013 Dec;98(12):4727-35. doi: 10.1210/jc.2013-2020. Epub 2013 Sep 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
247
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has been postmenopausal for at least 5 years
  • Patient has taken or is taking alendronate
  • Patient agrees not to use medications for osteoporosis other than what is provided by the study

Exclusion Criteria:

  • Patient has a history or evidence of hip fracture
  • Patient has a history of cancer within 5 years of screening, except certain skin or cervical cancers.
  • Patient has active parathyroid disease
  • Patient has a history of thyroid disease not adequately controlled by medication
  • Patient is taking anti-seizure medication and has abnormal calcium metabolism
  • Patient has received any bisphosphonate other than alendronate for 20% of the last 3 years, or within 3 months of screening
Female
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00885170
0822-042, 2009_578, CTRI/2009/091/000218
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP