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: February 19, 2014
Last verified: February 2014

September 12, 2007
February 19, 2014
September 2007
November 2012   (final data collection date for primary outcome measure)
  • (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 ]
Not Provided
Complete list of historical versions of study NCT00529373 on ClinicalTrials.gov Archive Site
  • (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 ]
Not Provided
Not Provided
Not Provided
 
A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Postmenopausal Osteoporosis
  • Drug: Odanacatib
    50 mg tablet orally once weekly
    Other Name: MK-0822
  • Drug: Placebo for Odanacatib
    50 mg tablet orally once weekly
  • Dietary Supplement: Vitamin D3
    5600 IU orally once weekly
  • 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.
    Interventions:
    • Drug: Odanacatib
    • Dietary Supplement: Vitamin D3
  • 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.
    Interventions:
    • Drug: Placebo for Odanacatib
    • Dietary Supplement: Vitamin D3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
16716
November 2014
November 2012   (final data collection date for primary outcome measure)

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
Female
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00529373
0822-018, 2007_610
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2014

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