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NCT Number: NCT01290094

A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis

This single arm, open label study will assess the efficacy and safety of and compliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg intravenously every three months. Anticipated time on study treatment is 12 months with a follow-up of 12 months.

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Key information

Conditions

Post Menopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Banja Luka, Bosnia and Herzegovina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients, > 50 years of age
  • Diagnosed osteoporosis
  • Bone mineral density < minus 2.5 SD or osteoporotic fracture
  • At least 3 years after menopause

Exclusion criteria

  • Impaired renal function
  • Contra-indication to Calcium or Vitamin D therapy
  • Previous or current treatment with biphosphonates

Treatment and study plan

ibandronate [Bonviva/Boniva]

Drug

3 mg intravenously every 3 months

Primary outcomes

  1. Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12

    Time frame: Baseline, Month 12

    Percent change was calculated as [(measure at time "t" minus [-] measure at baseline) divided by (/) measure at baseline] multiplied by (*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.

  2. Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24

    Time frame: Baseline, Month 24

    Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.

  3. Percent Change From Baseline in Mean Hip Bone BMD at Month 12

    Time frame: Baseline, Month 12

    Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.

  4. Percent Change From Baseline in Mean Hip BMD at Month 24

    Time frame: Baseline, Month 24

    Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.

Secondary outcomes

  1. Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24

    Time frame: Baseline, Month 12, Month 24

    Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.

  2. Percent Change From Baseline in Total Hip T-score at Month 12 and 24

    Time frame: Baseline, Month 12, Month 24

    Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis.

  3. Percentage of Participants Who Received All Planned Study Medication (Compliance)

    Time frame: Baseline up to Month 12

  4. Correlation Coefficient of Participant's Profile With Compliance

    Time frame: Baseline up to Month 12

    Participant's profile included age, year since menopause, fracture history, and BMD at baseline.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Interventional, Single Arm, Open Label Study of the Efficacy, Safety and Compliance to the Treatment With Intravenous (IV) Ibandronate (Bonviva®) in the Postmenopausal Osteoporosis Treatment of Bisphosphonates naïve Patients in Daily Practice

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2011
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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