Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)

Phase 3

Completed

• Conditions: Osteoporosis
• Interventions: Drug: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet

• Registration Number: NCT01437111
• Lead Sponsor: Organon and Co

Brief Summary

This study will assess the effect of 26 weeks of once-weekly treatment with MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) on serum levels of 25-hydroxyvitamin D \[25(OH)D\].

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-09-19
• Study First Posted: 2011-09-20
• Study Start: 2011-10-26
• Primary Completion: 2012-12-05
• Study Completion: 2012-12-05
• Results First Submitted: 2013-12-03
• Results First Submitted QC: 2013-12-03
• Results First Posted: 2014-01-22
• Status Verified: 2022-02
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Man aged 50 or older, or a woman who is postmenopausal on day of signing informed consent or has been menopausal for at least one year
• Meets bone mineral density (BMD) criteria
• Agree to discontinue any osteoporosis drug treatment for duration of study

Exclusion Criteria

• Any contraindication to alendronate and vitamin D
• Not ambulatory
• Has received treatment with any anabolic steroid agent within the past 12 months, systemic glucocorticoids, for more than 2 weeks in the past 6 months, current use of immunosuppressants, fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks within the past 3 months, treated with parathyroid hormone (PTH) for more than 2 weeks within the past 3 months, current use of chemotherapy or heparin, use of growth hormone for more than 2 weeks within the past 6 months, use of active hormonal vitamin D analogs in the past 2 months, current use of vitamin A >10,000 IU daily, current use of, lithium, or anti-convulsants including barbiturates, hydantoins, and carbamazepine, current use of calcium supplement in amount excess of 1500 mg daily, and/or current use of Vitamin D supplement
• History of malignancy <5 years, except adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer
• One or more of the following concomitant conditions: Upper gastrointestinal (GI) disorders not adequately controlled; myocardial infarction, unstable angina, stroke and revascularization condition within 3 months; malabsorption syndrome; primary or secondary hyperparathyroidism not adequately treated; thyroid disease not adequately controlled; severe renal insufficiency; uncontrolled genitourinary, cardiovascular, hepatic, renal, endocrine, hematologic, neurological, psychiatric, or pulmonary diseases; uncontrolled hypertension; new onset diabetes (within 3 months), poorly controlled hyperglycemia, or hypoglycemia for any cause; evidence for metabolic bone disease other than osteoporosis; abnormal indices of calcium metabolism; and/or active renal stone disease
• User of illicit recreational drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
• Heavy consumer of alcohol or alcohol containing products.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fosamax Plus	MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet	Calcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26	Week 26	Serum samples to measure serum 25-hydroxyvitamin D \[25(OH)D\] will be collected at specific visits during the treatment phase of the study.

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26	Baseline and Week 26	Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.