A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004)

NCT00112437 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 0822-0042005_023
• Study Type: interventional
• Target: 399
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a 1-year base study with a 1-year extension to examine the effects of a new experimental medication (odanacatib \[MK-0822\]) on postmenopausal osteoporosis. This study will enroll approximately 375 postmenopausal women, and randomly assign them to 4 different doses of odanacatib or to placebo. Measurements performed during the study include: bone mineral density scans, spine x-rays, laboratory blood and urine tests, height measurements and optional bone biopsies (at the end of 2 years).

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (7)

• Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months

  Percentage change in lumbar spine BMD (relative to baseline) at 12 Months.

  Baseline and 12 months

• Percentage Change From Baseline in Lumbar Spine BMD at 24 Months

  Percentage change in lumbar spine BMD (relative to baseline) at 24 Months.

  Baseline and 24 months

• Percentage Change From Baseline in Lumbar Spine BMD at 36 Months

  Percentage change in lumbar spine BMD (relative to baseline) at 36 months

  Baseline and 36 months

• Percentage Change From Baseline in Lumbar Spine BMD at 60 Months

  Percentage change from baseline in lumbar spine BMD at 60 months.

  Baseline and Month 60

• Percentage Change From Baseline in Lumbar Spine BMD at 120 Months

  Percentage change from baseline in lumbar spine BMD at 120 Months.

  Baseline and Month 120

• Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment Years 6-10 (60 Months)

  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.

  Years 6-10 (up to 60 months, up to 14 days after the last dose of study drug)

• Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Years 6-10 (60 Months)

  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.

  Years 6-10 (up to 60 months)

Secondary Outcomes (32)

• Percentage Change From Baseline in Total Hip BMD at 12 Months

  Baseline and 12 months

• Percentage Change From Baseline in Femoral Neck BMD at 12 Months

  Baseline and 12 months

• Percentage Change From Baseline in Trochanter BMD at 12 Months

  Baseline and 12 Months

• Percentage Change From Baseline in Total Body BMD at 12 Months

  Baseline and 12 Months

• Percentage Change From Baseline in Distal Forearm BMD at 12 Months

  Baseline and 12 Months

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium Carbonate; Drug: Placebo

Odanacatib 3 mg

EXPERIMENTAL

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

Odanacatib 10 mg

EXPERIMENTAL

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

Odanacatib 25 mg

EXPERIMENTAL

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

Odanacatib 50 mg

EXPERIMENTAL

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

Interventions

Odanacatib DRUG

Odanacatib 3 mg, once weekly for 24 months

Also known as: MK-0822

Odanacatib 3 mg

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3, two 2800 IU weekly throughout the study

Odanacatib 10 mg; Odanacatib 25 mg; Odanacatib 3 mg; Odanacatib 50 mg; Placebo

Calcium Carbonate DIETARY_SUPPLEMENT

Participants who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium.

Odanacatib 10 mg; Odanacatib 25 mg; Odanacatib 3 mg; Odanacatib 50 mg; Placebo

Placebo DRUG

Placebo to Odanacatib 3 mg, 10 mg, 25 mg, or 50 once weekly for 24 months

Placebo

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal for 5 or more years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy
• Bone mineral density T-score at the hip or spine of -2.0 or less
• Spinal anatomy suitable for dual-energy x-ray absorptiometry (DXA). At the lumbar spine, there is no evidence of vertebral fracture in at least 3 vertebrae in the L1 to L4 region on baseline spine films. (Significant scoliosis, bony trauma, degenerative joint disease, and sequelae of orthopedic procedures that result in anatomy that is unsuitable for accurate bone densitometry must be absent from the lumbar spine.)
• At least one hip must be evaluable by DXA (e.g., contain no hardware from orthopedic procedures)
• In a state of general health allowing for successful completion of the trial
• Agreement to not use any medications to treat osteoporosis during the study

You may not qualify if:

• History of prior osteoporotic fracture (unless declined treatment with or was ineligible for osteoporosis therapy)
• Significant clinical or laboratory abnormalities at the screening visit for the study that, in the opinion of the investigator, could complicate interpretation of the study results or pose additional risk to the patient (for example, patients who are non-ambulatory should be excluded for this reason)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (4)

• Bone HG, McClung MR, Roux C, Recker RR, Eisman JA, Verbruggen N, Hustad CM, DaSilva C, Santora AC, Ince BA. Odanacatib, a cathepsin-K inhibitor for osteoporosis: a two-year study in postmenopausal women with low bone density. J Bone Miner Res. 2010 May;25(5):937-47. doi: 10.1359/jbmr.091035.

  PMID: 19874198 RESULT

• Langdahl B, Binkley N, Bone H, Gilchrist N, Resch H, Rodriguez Portales J, Denker A, Lombardi A, Le Bailly De Tilleghem C, Dasilva C, Rosenberg E, Leung A. Odanacatib in the treatment of postmenopausal women with low bone mineral density: five years of continued therapy in a phase 2 study. J Bone Miner Res. 2012 Nov;27(11):2251-8. doi: 10.1002/jbmr.1695.

  PMID: 22777865 RESULT

• Rizzoli R, Benhamou CL, Halse J, Miller PD, Reid IR, Rodriguez Portales JA, DaSilva C, Kroon R, Verbruggen N, Leung AT, Gurner D. Continuous treatment with odanacatib for up to 8 years in postmenopausal women with low bone mineral density: a phase 2 study. Osteoporos Int. 2016 Jun;27(6):2099-107. doi: 10.1007/s00198-016-3503-0. Epub 2016 Feb 15.

  PMID: 26879200 RESULT

• Eisman JA, Bone HG, Hosking DJ, McClung MR, Reid IR, Rizzoli R, Resch H, Verbruggen N, Hustad CM, DaSilva C, Petrovic R, Santora AC, Ince BA, Lombardi A. Odanacatib in the treatment of postmenopausal women with low bone mineral density: three-year continued therapy and resolution of effect. J Bone Miner Res. 2011 Feb;26(2):242-51. doi: 10.1002/jbmr.212.

  PMID: 20740685 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 Monitor

  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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2005
• First Posted: June 3, 2005
• Study Start: June 24, 2005
• Primary Completion: December 26, 2007
• Study Completion: January 20, 2016
• Last Updated: January 24, 2018
• Results First Posted: May 13, 2010

Record last verified: 2017-12