A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00529373
First received: September 12, 2007
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

The purpose of the event-driven base study is to determine the safety and efficacy, especially fracture-risk reduction, of odanacatib in postmenopausal women diagnosed with osteoporosis. In a placebo-controlled extension of the base study, participants continue to receive the same blinded study medication for a total of up to 5 years of blinded study medication combined between the base study and the extension. After all participants receive at least 5 years of blinded study medication, they will be invited to enroll into a second extension study in which they will receive open-label odanacatib for an additional 5 years.


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: Odanacatib
Drug: Placebo for Odanacatib
Dietary Supplement: Vitamin D3
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium

Resource links provided by NLM:


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

Primary Outcome Measures:
  • (Base Study) Time From Baseline to First Morphometrically-Assessed Vertebral Fracture [ Time Frame: Up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study) Time From Baseline to First Hip Fracture (Adjudicated as Osteoporotic) [ Time Frame: Up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study) Time From Baseline to First Clinical Non-Vertebral Fracture (Adjudicated as Osteoporotic) [ Time Frame: Up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Imaging Substudy PN032) Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) at the Lumbar Spine Using Quantitative Computed Tomography [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
  • (Base Study + 1st Extension) Time From Baseline to First Morphometrically-Assessed Vertebral Fracture [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • (Base Study + 1st Extension) Time From Baseline to First Hip Fracture (Adjudicated as Osteoporotic) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • (Base Study + 1st Extension) Time From Baseline to First Clinical Non-Vertebral Fracture (Adjudicated as Osteoporotic) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • (2nd Extension) Percent Change From Baseline in BMD Measurements of the Total Hip [ Time Frame: Baseline and once yearly up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • (Base Study) Time From Baseline to First Clinical Osteoporotic Vertebral Fracture (Adjudicated) [ Time Frame: Up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study) Change in Height From Baseline Stature [ Time Frame: Baseline and once yearly up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study) Percent Change from Baseline in BMD Measurements of the Lumbar Spine [ Time Frame: Baseline and once yearly up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study) Change From Baseline in Serum C-Telopeptides of Type I Collagen (s-CTx) After Log-Transformation [ Time Frame: Baseline and once yearly up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Imaging Substudy PN032) Percent Change From Baseline in Cortical Volumetric BMD of the Hip Using Quantitative Computed Tomography [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
  • (Base Study) Percent Change from Baseline in BMD Measurements of the Total Hip [ Time Frame: Baseline and once yearly up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study) Percent Change from Baseline in BMD Measurements of the Femoral Neck [ Time Frame: Baseline and once yearly up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study) Percent Change from Baseline in BMD Measurements of the Trochanter [ Time Frame: Baseline and once yearly up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study) Percent Change from Baseline in BMD Measurements of the Distal-Third Forearm [ Time Frame: Baseline and once yearly up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study) Percent Change From Baseline in BMD Measurements of the Lumbar Spine in Bisphosphonate-Intolerant Participants [ Time Frame: Baseline and once yearly up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study) Percent Change From Baseline in BMD Measurements of the Total Hip in Bisphosphonate-Intolerant Participants [ Time Frame: Baseline and once yearly up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study) Percent Change From Baseline in BMD Measurements of the Femoral Neck in Bisphosphonate-Intolerant Participants [ Time Frame: Baseline and once yearly up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study) Percent Change From Baseline in BMD Measurements of the Trochanter in Bisphosphonate-Intolerant Participants [ Time Frame: Baseline and once yearly up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study) Percent Change From Baseline in BMD Measurements of the Distal-Third Forearm in Bisphosphonate-Intolerant Participants [ Time Frame: Baseline and once yearly up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study) Change From Baseline in Urinary N-Telopeptides of Type I Collagen (u-NTx) After Log-Transformation [ Time Frame: Baseline and once yearly up to 5 years (Data cutoff November 2012) ] [ Designated as safety issue: No ]
  • (Base Study + 1st Extension + 2nd Extension) Time From Baseline to First Clinical Osteoporotic Vertebral Fracture (Adjudicated) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • (Base Study + 1st Extension + 2nd Extension) Time From Baseline to First Clinical Fracture of Any Type (Adjudicated) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • (Base Study + 1st Extension + 2nd Extension) Change in Height From Baseline Stature [ Time Frame: Baseline and once yearly up to 10 years ] [ Designated as safety issue: No ]
  • (Base Study + 1st Extension + 2nd Extension) Percent Change from Baseline in BMD Measurements of the Lumbar Spine [ Time Frame: Baseline and once yearly up to 10 years ] [ Designated as safety issue: No ]
  • (Base Study + 1st Extension + 2nd Extension) Percent Change from Baseline in BMD Measurements of the Femoral Neck [ Time Frame: Baseline and once yearly up to 10 years ] [ Designated as safety issue: No ]
  • (Base Study + 1st Extension + 2nd Extension) Percent Change from Baseline in BMD Measurements of the Trochanter [ Time Frame: Baseline and once yearly up to 10 years ] [ Designated as safety issue: No ]
  • (2nd Extension) Time From Baseline to First Morphometrically-Assessed Vertebral Fracture [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Enrollment: 16716
Study Start Date: September 2007
Estimated Study Completion Date: November 2014
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Odanacatib
Participants receive 50 mg of blinded odanacatib weekly over the course of the base study and first extension study (5 years total), followed by 50 mg of open-label odanacatib weekly for 5 years. All participants will also receive Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is at least 1200 mg.
Drug: Odanacatib
50 mg tablet orally once weekly
Other Name: MK-0822
Dietary Supplement: Vitamin D3
5600 IU orally once weekly
Placebo Comparator: Placebo
Participants receive 50 mg of blinded placebo to odanacatib weekly over the course of the base study and first extension study (5 years total), followed by 50 mg of open-label odanacatib weekly for 5 years. All participants will also receive Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is at least 1200 mg.
Drug: Placebo for Odanacatib
50 mg tablet orally once weekly
Dietary Supplement: Vitamin D3
5600 IU orally once weekly

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women (for at least 5 years) who are ≥65 years of age and have low bone mineral density
  • Ambulatory (able to walk)

Exclusion Criteria:

  • Must not be taking osteoporosis therapy or have a metabolic bone disorder other than osteoporosis
  • Has or has had a hip fracture
  • Currently participating in another drug study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00529373     History of Changes
Other Study ID Numbers: 0822-018, 2007_610
Study First Received: September 12, 2007
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014