Clinical Trials Logo

Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT00493532
Other study ID # ML20882
Secondary ID
Status No longer available
Phase Phase 4
First received June 27, 2007
Last updated November 1, 2016
Start date June 2007
Est. completion date December 2010

Study information

Verified date November 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Expanded Access

Clinical Trial Summary

This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Female
Age group N/A to 80 Years
Eligibility Inclusion Criteria:

- post-menopausal women with osteoporosis;

- <=80 years of age;

- naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for >1 year.

Exclusion Criteria:

- metabolic bone disease other than post-menopausal osteoporosis;

- treatment with other drugs affecting bone metabolism within last 6 months;

- previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).

Study Design

N/A


Intervention

Drug:
ibandronate [Bonviva/Boniva]
3mg iv every 3 months

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Taiwan, 

See also
  Status Clinical Trial Phase
Completed NCT05087030 - Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis Phase 3
Completed NCT01544894 - Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis Phase 4
Completed NCT00381251 - Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. Phase 1
Completed NCT00377819 - Study of Transitioning From Alendronate to Denosumab Phase 3
Completed NCT00239629 - Teriparatide and Strontium Ranelate Head-To-Head Comparison Trial Phase 4
Completed NCT04026256 - Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration Phase 4
Terminated NCT00529373 - A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018) Phase 3
Completed NCT00092014 - A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211) Phase 3
Recruiting NCT06079476 - A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture. Phase 4
Not yet recruiting NCT04719650 - Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid Phase 4
Recruiting NCT02981732 - CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome N/A
Completed NCT01709110 - VERtebral Fracture Treatment Comparisons in Osteoporotic Women Phase 4
Completed NCT01348243 - Efficacy Of Clodronate 200 Mg/4 Ml I.M. Solution With 1% Lidocaine Every Other Week Vs Clodronate 100 Mg/3,3ml I.M. Solution With 1% Lidocaine Once-Week In A 1-Year Treatment Period Of Women With Postmenopausal Osteoporosis Phase 3
Completed NCT00541658 - A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis Phase 3
Completed NCT00395395 - Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women Phase 1
Completed NCT00247273 - A Study of Monthly Risedronate for Osteoporosis Phase 3
Active, not recruiting NCT03720886 - G56W1 in Women With Postmenopausal Osteoporosis Phase 1/Phase 2
Completed NCT01668589 - Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis N/A
Completed NCT04664959 - A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis Phase 3
Not yet recruiting NCT04719481 - Pravastatin Reduces Acute Phase Response of Zoledronic Acid Phase 4