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

NCT ID: NCT01437111

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-26
• Study Completion Date: 2012-12-05

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].

Conditions

Osteoporosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fosamax Plus

Calcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants

Group Type: EXPERIMENTAL

MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet

Intervention Type: DRUG

One combination tablet orally once a week

Interventions

MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet

One combination tablet orally once a week

Intervention Type: DRUG

Other Intervention Names

Fosamax Plus 70/5600

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Songpatanasilp T, Rojanasthien S, Sugkraroek P, Ongphiphadhanakul B, Robert L, Robert CS, Luevitoonvechkij S, Santora AC. Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand. BMC Musculoskelet Disord. 2018 Nov 6;19(1):392. doi: 10.1186/s12891-018-2309-y.

Reference Type: DERIVED

PMID: 30400864 (View on PubMed)

Other Identifiers

0217A-329

Identifier Type: -

Identifier Source: org_study_id