Study of Investigational Drug in Osteoporosis (MK-0217-908)

NCT00092053 | Completed Phase 3

• 1 other identifier: 0217-908
• Study Type: interventional
• Target: 203
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis. The primary hypothesis of this study is that in postmenopausal women with osteoporosis, oral monthly ibandronate, at doses of 100 mg and 150 mg, does not achieve persistence in reduction of bone resorption throughout the monthly dosing interval, as demonstrated by a larger change in the serum carboxyterminal crosslinked telopeptide of Type I collagen (CTX-I) log-transformed fraction from baseline four weeks post dose compared to one week post dose, during the third month of treatment, in the participants taking ibandronate than in the participants taking placebo.

Conditions

Postmenopausal Osteoporosis

Keywords

Postmenopausal; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Change in serum levels of CTX-I (log-transformed fraction) from Week 9 to Week 12

  Baseline, Week 9, Week 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will receive 3 placebo tablets once a month, for 3 months, on the first day of each treatment cycle.

Drug: Placebo

ibandronate 100 mg

EXPERIMENTAL

Participants will receive 2 ibandronate 50 mg tablets and 1 placebo tablet once a month, for 3 months, on the first day of each treatment cycle.

Drug: ibandronate

ibandronate 150 mg

EXPERIMENTAL

Participants will receive 3 ibandronate 50 mg tablets once a month, for 3 months, on the first day of each treatment cycle.

Drug: ibandronate

Interventions

Placebo DRUG

tablets

Placebo

ibandronate DRUG

50 mg tablets

ibandronate 100 mg; ibandronate 150 mg

Eligibility Criteria

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

You may not qualify if:

• participated in another therapeutic trial with an investigational compound within 30 days of randomization.
• history of hypersensitivity to any component of ibandronate tablets or has hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• an abnormality of the esophagus which delays esophageal emptying such as stricture or achalasia.
• unable to stand or sit upright for at least 60 minutes once a month.
• current use of illicit drugs, or history of drug or alcohol abuse within the past five years.
• has any of the following: hypocalcemia; any severe malabsorption syndrome; moderate or severe hypertension which is uncontrolled; new onset angina or myocardial infarction within six months of entry into the study; evidence for impaired renal function; organ transplantation; or other significant end organ diseases (genitourinary, cardiovascular, endocrine, hepatic, psychiatric, renal, hematologic, or pulmonary).
• history of or evidence of metabolic bone disease (other than postmenopausal bone loss).
• clinical fracture in the past year.
• is receiving or has received treatment prior to randomization which might influence bone turnover.
• is receiving or expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism, including Vitamin A in excess of 10,000 IU per day or Vitamin D in excess of 5000 IU per day, calcitonin, phenytoin, heparin, or lithium.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2004
• First Posted: September 24, 2004
• Study Start: December 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: February 2, 2022

Record last verified: 2022-02