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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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01552122
First received: March 9, 2012
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   60 Years and older
Genders 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

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01552122     History of Changes
Other Study ID Numbers: 0822-050
Study First Received: March 9, 2012
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013