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

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ClinicalTrials.gov Identifier: NCT02598934
Recruitment Status : Completed
First Posted : November 6, 2015
Results First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Post Menopausal Osteoporosis Drug: Ibandronate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Open-Label, Multicenter Study to Evaluate the Change in Bone Turnover Markers After Once Monthly Oral Ibandronate Therapy in Treatment Naive Postmenopausal Osteoporosis Patients
Study Start Date : August 2004
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: Ibandronate Group 1
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
Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Other Name: Bonviva/Boniva

Experimental: Ibandronate Group 2
Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation.
Drug: Ibandronate
Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Other Name: Bonviva/Boniva




Primary Outcome Measures :
  1. Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX) [ Time Frame: Baseline, Month 6 ]
    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).


Secondary Outcome Measures :
  1. Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX) [ Time Frame: Baseline, Month 6 ]
    Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. 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).

  2. Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) [ Time Frame: Baseline, Month 6 ]
    Serum P1NP is a measure of bone resorption and is measured as 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).

  3. Percent Change From Baseline to Month 6 in Serum Osteocalcin [ Time Frame: Baseline, Month 6 ]
    Serum osteocalcin is a measure of bone resorption and is measured as 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).

  4. Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP) [ Time Frame: Baseline, Month 6 ]
    Serum BSAP is a measure of bone resorption and is measured as 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).

  5. Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6 [ Time Frame: Month 6 ]
    The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture. Response options ranged on a 5-point scale from 'Not At All Confident' to 'Very Confident.' A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS. (1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598934


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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02598934     History of Changes
Other Study ID Numbers: ML18057
First Posted: November 6, 2015    Key Record Dates
Results First Posted: March 9, 2016
Last Update Posted: March 9, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs