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Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01552122
First Posted: March 13, 2012
Last Update Posted: August 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Osteoporosis Postmenopausal Osteoporosis Drug: Odanacatib Drug: Alendronate Other: Placebo (odanacatib) Dietary Supplement: Cholecalciferol (Vitamin D3) Dietary Supplement: Calcium carbonate Other: Placebo (alendronate) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck [ Time Frame: Baseline and Month 24 ]

Secondary Outcome Measures:
  • Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter [ Time Frame: Baseline and Month 24 ]

Enrollment: 0
Study Start Date: May 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Odanacatib Drug: Odanacatib
Odanacatib 50 mg compressed tablet will be administered orally, once-a-week, for 24 months
Other Name: MK-0822
Dietary Supplement: Cholecalciferol (Vitamin D3)
Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.
Dietary Supplement: Calcium carbonate
Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.
Other: Placebo (alendronate)
One compressed tablet administered orally, once-a-week, for 24 months.
Active Comparator: Alendronate Drug: Alendronate
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.
Other Names:
  • Alendronate Sodium
  • Fosamax
Other: Placebo (odanacatib)
One compressed tablet administered orally, once-a-week, for 24 months.
Dietary Supplement: Cholecalciferol (Vitamin D3)
Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.
Dietary Supplement: Calcium carbonate
Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.

  Eligibility

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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™)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01552122     History of Changes
Other Study ID Numbers: 0822-050
First Submitted: March 9, 2012
First Posted: March 13, 2012
Last Update Posted: August 27, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Cholecalciferol
Alendronate
Calcium Carbonate
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents