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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Osteoporosis

Treatments: Dietary Supplement: Vitamin D3; Drug: Placebo; Drug: MK-5442; Dietary Supplement: Calcium carbonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960934

2009-012926-35 (EudraCT Number)

5442-001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 383 patients

Sex: Female

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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383 participants in 6 patient groups, including a placebo group

MK-5442 2.5 mg

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D3

Drug: MK-5442

Drug: Placebo

Dietary Supplement: Calcium carbonate

MK-5442 5 mg

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D3

Drug: MK-5442

Drug: Placebo

Dietary Supplement: Calcium carbonate

MK-5442 7.5 mg

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D3

Drug: MK-5442

Drug: Placebo

Dietary Supplement: Calcium carbonate

MK-5442 10 mg

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D3

Drug: MK-5442

Drug: Placebo

Dietary Supplement: Calcium carbonate

MK-5442 15 mg

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D3

Drug: MK-5442

Drug: Placebo

Dietary Supplement: Calcium carbonate

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D3

Drug: Placebo

Dietary Supplement: Calcium carbonate