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

NCT01437111 | Completed Phase 3 Results

• 1 other identifier: 0217A-329
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Keywords

Osteoporosis; Postmenopausal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26

  Baseline and Week 26

Study Arms (1)

Fosamax Plus

EXPERIMENTAL

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

Interventions

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

One combination tablet orally once a week

Also known as: Fosamax Plus 70/5600

Fosamax Plus

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 30400864 DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Cholecalciferol; Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 20, 2011
• Study Start: October 26, 2011
• Primary Completion: December 5, 2012
• Study Completion: December 5, 2012
• Last Updated: April 22, 2024
• Results First Posted: January 22, 2014

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share