A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)

NCT01120600 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 0822-0532010_532
• Study Type: interventional
• Target: 294
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (3)

• Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24

  Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.

  Baseline and Month 24

• Number of Participants Who Experienced an Adverse Event (AE)

  An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.

  Up to 24 months (plus 14 days) after first dose of study drug

• Number of Participants Who Discontinued Treatment Due to an AE

  An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.

  Up to 24 months after first dose of study drug

Secondary Outcomes (7)

• Percentage Change From Baseline in Total Hip BMD at Month 24

  Baseline and Month 24

• Percentage Change From Baseline in Femoral Neck BMD at Month 24

  Baseline and Month 24

• Percentage Change From Baseline in Trochanter BMD at Month 24

  Baseline and Month 24

• Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24

  Baseline and Month 24

• Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24

  Baseline and Month 24

Study Arms (2)

Odanacatib 50 mg once weekly

EXPERIMENTAL

Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.

Drug: Odanacatib; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate

Placebo once weekly

PLACEBO COMPARATOR

Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.

Drug: Placebo for Odanacatib; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate

Interventions

Odanacatib DRUG

One 50 mg tablet once weekly

Also known as: MK-0822

Odanacatib 50 mg once weekly

Placebo for Odanacatib DRUG

One 50 mg tablet once weekly

Placebo once weekly

Vitamin D3 DIETARY_SUPPLEMENT

5600 IU of open-label Vitamin D3 once weekly

Odanacatib 50 mg once weekly; Placebo once weekly

Calcium carbonate DIETARY_SUPPLEMENT

Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg

Odanacatib 50 mg once weekly; Placebo once weekly

Eligibility Criteria

• Age: 40 Years - 95 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a male between 40 and 95 years of age
• Has osteoporosis
• Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar spine and and hip
• Is ambulatory

You may not qualify if:

• Is currently on oral bisphosphonates or other treatment for osteoporosis
• Had previous hip fragility fracture and is a candidate for standard of care therapy
• Has had a fragility fracture (vertebral or non-vertebral fractures indicating reduced bone strength) within 12 months
• Has had more then one previous vertebral fracture
• Has been diagnosed with metabolic bone disorder other than osteoporosis
• Is Vitamin D deficient
• Has a history of renal stones
• Has active parathyroid disease
• Has history of thyroid disease not well controlled by medication
• Is diagnosed with secondary osteoporosis
• Has a daily calcium intake of \<1,200 mg and is unwilling to take study prescribed supplements or increase dietary intake, such that his daily calcium intake is at least 1200 mg
• Has a history of malignancy ≤5 years prior to signing informed consent
• Has been diagnosed with hypogonadism due to causes that affect multiple organ and body systems

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Binkley N, Orwoll E, Chapurlat R, Langdahl BL, Scott BB, Giezek H, Santora AC. Randomized, controlled trial to assess the safety and efficacy of odanacatib in the treatment of men with osteoporosis. Osteoporos Int. 2021 Jan;32(1):173-184. doi: 10.1007/s00198-020-05701-9. Epub 2020 Nov 17.

  PMID: 33200257 DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

odanacatib; Cholecalciferol; Calcium Carbonate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 11, 2010
• Study Start: June 9, 2010
• Primary Completion: July 22, 2013
• Study Completion: July 22, 2013
• Last Updated: August 28, 2018
• Results First Posted: December 6, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share