A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001)

NCT ID: NCT00960934

Last Updated: 2015-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 383 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-12-31

Brief Summary

The purpose of this study was to identify an appropriate dose of

MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal women with osteoporosis.

Detailed Description

Amendment 4 of the protocol changed the duration of the study from 2 years to 6 months.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MK-5442 2.5 mg

Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.

Group Type: EXPERIMENTAL

MK-5442

Intervention Type: DRUG

MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months.

Placebo

Intervention Type: DRUG

Dose-matched oral placebo to MK-5442

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3, two 400 IU tablets daily throughout the study.

Calcium carbonate

Intervention Type: DIETARY_SUPPLEMENT

Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.

MK-5442 5 mg

Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.

Group Type: EXPERIMENTAL

MK-5442

Intervention Type: DRUG

MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months.

Placebo

Intervention Type: DRUG

Dose-matched oral placebo to MK-5442

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3, two 400 IU tablets daily throughout the study.

Calcium carbonate

Intervention Type: DIETARY_SUPPLEMENT

Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.

MK-5442 7.5 mg

Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.

Group Type: EXPERIMENTAL

MK-5442

Intervention Type: DRUG

MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months.

Placebo

Intervention Type: DRUG

Dose-matched oral placebo to MK-5442

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3, two 400 IU tablets daily throughout the study.

Calcium carbonate

Intervention Type: DIETARY_SUPPLEMENT

Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.

MK-5442 10 mg

Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.

Group Type: EXPERIMENTAL

MK-5442

Intervention Type: DRUG

MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months.

Placebo

Intervention Type: DRUG

Dose-matched oral placebo to MK-5442

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3, two 400 IU tablets daily throughout the study.

Calcium carbonate

Intervention Type: DIETARY_SUPPLEMENT

Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.

MK-5442 15 mg

Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.

Group Type: EXPERIMENTAL

MK-5442

Intervention Type: DRUG

MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months.

Placebo

Intervention Type: DRUG

Dose-matched oral placebo to MK-5442

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3, two 400 IU tablets daily throughout the study.

Calcium carbonate

Intervention Type: DIETARY_SUPPLEMENT

Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.

Placebo

Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dose-matched oral placebo to MK-5442

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3, two 400 IU tablets daily throughout the study.

Calcium carbonate

Intervention Type: DIETARY_SUPPLEMENT

Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.

Interventions

MK-5442

MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months.

Intervention Type: DRUG

Placebo

Dose-matched oral placebo to MK-5442

Intervention Type: DRUG

Vitamin D3

Vitamin D3, two 400 IU tablets daily throughout the study.

Intervention Type: DIETARY_SUPPLEMENT

Calcium carbonate

Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Postmenopausal for at least 5 years
• No history of fragility fracture, unless participant is not willing to take marketed osteoporosis therapy or is not a candidate for marketed osteoporosis therapy
• Agrees not to use medications for osteoporosis except medications associated with the study
• Areal bone mineral density (BMD) T-score <-2.5 at one or more of the following 4 BMD sites: total hip, femoral neck, trochanter, or lumbar spine and is ≥ -3.5 at all 4 BMD sites. Participants unwilling to take or ineligible for marketed osteoporosis therapy may have one or more areal BMD T-scores of < -3.5

Exclusion Criteria

• Unable to undergo dual-energy X-ray absorptiometry (DXA) scan due to obesity (ie, weight >250 lbs)
• Use of oral bisphosphonates in the 6 months prior to study screening, for more than 3 months in the past 2 years, or lifetime use of more than 6 months
• Use of intravenous bisphosphonates, strontium, or growth hormone at any time
• Use of phenytoin or heparin within 2 weeks prior to Visit 1; use of raloxifene within 6 months prior to Visit 1
• Use of pioglitazone or rosiglitazone at study screening
• Use of estrogen ± progestin, in any form other than vaginal or topical application, for 6 months prior to Study Visit 1
• Prior total thyroidectomy
• Human immunodeficiency virus (HIV)- positive or acquired immune deficiency syndrome (AIDS)-related illness
• History of malignant cancer within 5 years of study screening, except for certain skin or cervical cancers
• History of Paget's disease and/or kidney stones
• An active user of any illicit drug
• History of or active alcohol abuse
• Participated in an investigational drug study within the past 30 days

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Halse J, Greenspan S, Cosman F, Ellis G, Santora A, Leung A, Heyden N, Samanta S, Doleckyj S, Rosenberg E, Denker AE. A phase 2, randomized, placebo-controlled, dose-ranging study of the calcium-sensing receptor antagonist MK-5442 in the treatment of postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2014 Nov;99(11):E2207-15. doi: 10.1210/jc.2013-4009. Epub 2014 Aug 28.

Reference Type: RESULT

PMID: 25166719 (View on PubMed)

Other Identifiers

2009-012926-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

5442-001

Identifier Type: -

Identifier Source: org_study_id