Overview

This trial is active, not recruiting.

Condition postmenopausal osteoporosis
Treatments odanacatib, placebo for odanacatib, vitamin d3
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date September 2007
End date November 2012
Trial size 16716 participants
Trial identifier NCT00529373, 0822-018, 132238, 2007_610

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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 approximately 1200 mg.
odanacatib MK-0822
50 mg tablet orally once weekly
vitamin d3
5600 IU orally once weekly
(Placebo Comparator)
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 approximately 1200 mg.
placebo for odanacatib
50 mg tablet orally once weekly
vitamin d3
5600 IU orally once weekly

Primary Outcomes

Measure
(Base Study) Time From Baseline to First Morphometrically-Assessed Vertebral Fracture
time frame: Up to 5 years (Data cutoff November 2012)
(Base Study) Time From Baseline to First Hip Fracture (Adjudicated as Osteoporotic)
time frame: Up to 5 years (Data cutoff November 2012)
(Base Study) Time From Baseline to First Clinical Non-Vertebral Fracture (Adjudicated as Osteoporotic)
time frame: Up to 5 years (Data cutoff November 2012)
(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
(Base Study + 1st Extension) Time From Baseline to First Morphometrically-Assessed Vertebral Fracture
time frame: Up to 5 years
(Base Study + 1st Extension) Time From Baseline to First Hip Fracture (Adjudicated as Osteoporotic)
time frame: Up to 5 years
(Base Study + 1st Extension) Time From Baseline to First Clinical Non-Vertebral Fracture (Adjudicated as Osteoporotic)
time frame: Up to 5 years
(2nd Extension) Percent Change From Baseline in BMD Measurements of the Total Hip
time frame: Baseline and once yearly up to 10 years
(Sarcopenia Substudy PN035) Percent Change from Baseline in Appendicular Lean Body Mass (aLBM)
time frame: Baseline and once yearly up to 4 years
(Sarcopenia Substudy PN035) Percent Change from Baseline in Short Physical Performance Battery (SPPB) Score
time frame: Baseline and once yearly up to 4 years
(Sarcopenia Substudy PN035) Percent Change from Baseline in Gait Speed
time frame: Baseline and once yearly up to 4 years.

Secondary Outcomes

Measure
(Base Study) Time From Baseline to First Clinical Osteoporotic Vertebral Fracture (Adjudicated)
time frame: Up to 5 years (Data cutoff November 2012)
(Base Study) Change in Height From Baseline Stature
time frame: Baseline and once yearly up to 5 years (Data cutoff November 2012)
(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)
(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)
(Imaging Substudy PN032) Percent Change From Baseline in Cortical Volumetric BMD of the Hip Using Quantitative Computed Tomography
time frame: Baseline to Month 24
(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)
(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)
(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)
(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)
(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)
(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)
(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)
(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)
(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)
(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)
(Base Study + 1st Extension + 2nd Extension) Time From Baseline to First Clinical Osteoporotic Vertebral Fracture (Adjudicated)
time frame: Up to 10 years
(Base Study + 1st Extension + 2nd Extension) Time From Baseline to First Clinical Fracture of Any Type (Adjudicated)
time frame: Up to 10 years
(Base Study + 1st Extension + 2nd Extension) Change in Height From Baseline Stature
time frame: Baseline and once yearly up to 10 years
(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
(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
(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
(2nd Extension) Time From Baseline to First Morphometrically-Assessed Vertebral Fracture
time frame: Up to 10 years

Eligibility Criteria

Female participants at least 65 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..