Clinical trial NCT01437111: Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Osteoporosis
Postmenopausal
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-09-20
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 \[25(OH)D\].


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.

Primary outcomes:
measure: Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26
timeFrame: Week 26
Secondary outcomes:
measure: Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26
timeFrame: Baseline and Week 26
Other outcomes:
Locations:
Study officials:
References:
citation: 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.