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

Purpose

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].

Condition	Intervention	Phase
Osteoporosis	Drug: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis Vitamin D

Drug Information available for: Cholecalciferol Vitamin D Alendronate sodium

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
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:

Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.


Enrollment:	200
Study Start Date:	October 2011
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fosamax Plus Calcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants	Drug: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet One combination tablet orally once a week Other Name: Fosamax Plus 70/5600

Eligibility


Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01437111 History of Changes
Other Study ID Numbers:	0217A-329
Study First Received:	September 19, 2011
Results First Received:	December 3, 2013
Last Updated:	January 29, 2015
Health Authority:	Thailand: Ethical Committee

Keywords provided by Merck Sharp & Dohme Corp.:


Osteoporosis Postmenopausal

Additional relevant MeSH terms:


Osteoporosis Bone Diseases Bone Diseases, Metabolic Musculoskeletal Diseases Alendronate Cholecalciferol Vitamin D	Vitamins Bone Density Conservation Agents Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015