A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis

NCT02598934 | Completed Phase 4 Results

• 1 other identifier: ML18057
• Study Type: interventional
• Target: 308
• Locations: 2 countries
• Sites: 53

Brief Summary

This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.

Conditions

Post Menopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)

  Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).

  Baseline, Month 6

Secondary Outcomes (5)

• Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)

  Baseline, Month 6

• Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)

  Baseline, Month 6

• Percent Change From Baseline to Month 6 in Serum Osteocalcin

  Baseline, Month 6

• Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)

  Baseline, Month 6

• Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6

  Month 6

Study Arms (2)

Ibandronate Group 1

EXPERIMENTAL

Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 1 will receive a physician consultation after 4 months of treatment to review bone turnover test results.

Drug: Ibandronate

Ibandronate Group 2

EXPERIMENTAL

Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation.

Drug: Ibandronate

Interventions

Ibandronate DRUG

Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.

Also known as: Bonviva/Boniva

Ibandronate Group 1; Ibandronate Group 2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women newly diagnosed with postmenopausal osteoporosis
• Naive to prior bisphosphonate therapy

You may not qualify if:

• Inability to stand or sit upright for at least 60 minutes
• Inability to swallow a tablet whole
• Hypersensitivity to any component of ibandronate
• Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
• Other osteoporosis drug within last 3 months
• Malignant disease diagnosed within previous 10 years, except resected basal cell cancer

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (53)

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Montgomery, Alabama, 36111, United States

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Chandler, Arizona, 85225, United States

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Peoria, Arizona, 85381, United States

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Hot Springs, Arkansas, 71913, United States

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Pine Bluff, Arkansas, 71603, United States

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Anaheim, California, 92801, United States

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Beverly Hills, California, 90211, United States

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Carmichael, California, 95608, United States

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Wilmington, Delaware, 19805, United States

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DeLand, Florida, 32720, United States

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Miami, Florida, 33176, United States

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Miami, Florida, 33186, United States

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Palm Habor, Florida, 34684, United States

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Palm Springs, Florida, 33461, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30309, United States

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Rome, Georgia, 30165, United States

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Morton Grove, Illinois, 60053, United States

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Indianapolis, Indiana, 46202, United States

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Waterloo, Iowa, 50702, United States

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Baltimore, Maryland, 21209, United States

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Hagerstown, Maryland, 21740, United States

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Reistertown, Maryland, 21136, United States

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Olive Branch, Mississippi, 38654, United States

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Jefferson City, Missouri, 65109, United States

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St Louis, Missouri, 63108, United States

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Omaha, Nebraska, 68131, United States

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Bloomfield, New Jersey, 07003, United States

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New York, New York, 10016, United States

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The Bronx, New York, 10461, United States

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Morehead City, North Carolina, 28557, United States

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Morganton, North Carolina, 28655, United States

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Raleigh, North Carolina, 27612, United States

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Oklahoma City, Oklahoma, 73112, United States

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Medford, Oregon, 97504, United States

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Doylestown, Pennsylvania, 18901, United States

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Langhorne, Pennsylvania, 19047, United States

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Philadelphia, Pennsylvania, 19131, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Spartanburg, South Carolina, 29307, United States

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Morristown, Tennessee, 37813, United States

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Murfreesboro, Tennessee, 37130, United States

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Nashville, Tennessee, 37203, United States

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Amarillo, Texas, 79106, United States

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Fort Worth, Texas, 76101, United States

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San Antonio, Texas, 78229, United States

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Texarkana, Texas, 75503, United States

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Richmond, Virginia, 23226, United States

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Tacoma, Washington, 98405, United States

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Madison, Wisconsin, 53705, United States

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Ponce, 00717-1318, Puerto Rico

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San Juan, 00927, Puerto Rico

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San Juan, 00935, Puerto Rico

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MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 6, 2015
• Study Start: August 1, 2004
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: March 9, 2016
• Results First Posted: March 9, 2016

Record last verified: 2016-02

Locations

PR (3); US (50)