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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
ClinicalTrials.gov Identifier:
NCT00885170
First received: April 20, 2009
Last updated: November 19, 2011
Last verified: November 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Osteoporosis
 Drug: odanacatib
Drug: Comparator: Placebo
Dietary Supplement: Vitamin D3
Dietary Supplement: Calcium
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Percent change in BMD from baseline at the femoral neck site assessed by DXA [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 247
Study Start Date: April 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
odanacatib
 Drug: odanacatib
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.
Placebo Comparator: 2
Placebo
 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885170

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00885170     History of Changes
Other Study ID Numbers: 2009_578, MK0822-042
Study First Received: April 20, 2009
Last Updated: November 19, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 16, 2013