Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Osteoporosis Postmenopausal

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620113

0822-022

2007_034 (Other Identifier)

MK-0822-022 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the dose-response on the percent change from baseline in lumbar spine bone mineral density (BMD) at lumbar vertebrae 1 to 4 (L1- L4) when odanacatib (MK-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52 weeks to Japanese involutional osteoporosis participants. The study will also assess safety and tolerability of odanacatib (10, 25, and 50 mg) in these participants.

The study will enroll approximately 280 participants and randomly assign them to 3 different doses of odanacatib or placebo for 52 weeks, along with supplemental vitamin D3 and calcium carbonate. The primary efficacy hypothesis is that a dose-response relationship on the percent change from baseline in lumbar spine BMD (L1- L4) is seen when odanacatib 10, 25, 50 mg or placebo is orally administered once weekly for 52 weeks to involutional osteoporosis participants. The primary safety hypothesis is that odanacatib will be safe and well tolerated over 52 weeks to involutional osteoporosis participants.

Enrollment: 287 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal woman (for at least 5 years) or men who are aged between 45 to 85
• Participant who has low bone mineral density
• Participant has anatomy suitable for dual-energy x-ray absorptiometry (DXA) of the lumber spine and hip
• Participant is ambulatory (can walk)

Exclusion criteria

• Participant has secondary osteoporosis or has a metabolic bone disorder other than osteoporosis or osteopenia
• Participant has received osteoporosis medications or other medications that affect bone
• Participant is already participating in another drug study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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287 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 International Units (IU) vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.

Treatment:

Drug: Placebo

Dietary Supplement: Calcium carbonate

Dietary Supplement: Vitamin D3

Odanacatib 10 mg

Experimental group

Description:

After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.

Treatment:

Dietary Supplement: Calcium carbonate

Drug: Odanacatib

Dietary Supplement: Vitamin D3

Odanacatib 25 mg

Experimental group

Description:

After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.

Treatment:

Dietary Supplement: Calcium carbonate

Drug: Odanacatib

Dietary Supplement: Vitamin D3

Odanacatib 50 mg

Placebo Comparator group

Description:

After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.

Treatment:

Dietary Supplement: Calcium carbonate

Drug: Odanacatib

Dietary Supplement: Vitamin D3