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

Osteoporosis Clinical Trial

Official title:

A Phase III (Phase IV Program) Open-Label, Multicenter Clinical Trial in Thailand to Study the Effect of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) for 6 Months on 25-Hydroxyvitamin D Levels in the Treatment of Osteoporosis in Postmenopausal Women and Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437111
• Other study ID #: 0217A-329
• Status: Completed
• Phase: Phase 3
• Start date: October 26, 2011
• Est. completion date: December 5, 2012

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 5, 2012
• Est. primary completion date: December 5, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet
One combination tablet orally once a week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at 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.	Week 26
Secondary	Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26	Serum samples for Beta-CrossLaps (ß-CTx) will be collected at specific visits during the treatment phase of the study.	Baseline and Week 26