-
Protocol Number:
BM16550
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.09.2005
Phase:
III
DIVA study. Randomized, Double-Blind, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of 2 intravenous (iv) Ibandronate Dose Regimens (2 mg q 2 mo, 3 mg q 3 mo) With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis.
-
Protocol Number:
ML19814
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
20.03.2007
Phase:
IV
A randomised, open-label, study to investigate the impact of bone-marker feedback after 3 and 6 months on adherence to once monthly ibandronate treatment.
-
Protocol Number:
ML19334
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
26.10.2007
Phase:
IV
A randomized, double-blind, placebo-controlled study to determine time to onset of suppression of the bone resorption marker sCTX with once-monthly ibandronate in the treatment of postmenopausal osteoporosis.
-
Protocol Number:
ML19324
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
13.05.2008
Phase:
IV
Adherence to once monthly treatment - ATOM
-
Protocol Number:
ML18058
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
05.01.2007
Phase:
IV
PRIOR Study--And open label, multi-center study to determine level of adherence to monthly oral or every three month intravenous ibandronate treatment in postmenopausal women with osteoporosis or osteopenia, who are GI intolerant of daily and/or weekly alendronate or risedronate.
-
Protocol Number:
MA19547
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.09.2008
Phase:
IV
Randomized, open-label, multi-center study to investigate patient preference on dosing in women with postmenopausal osteoporosis treated with once-monthly ibandronate and once-weekly risedronate. A six-month, two-sequence, and two-period crossover study.
-
Protocol Number:
MF4491
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.10.2001
Phase:
III
A multicenter, open label, randomized study on the efficacy and safety of oral ibandronate (BM 21.0955) 2.5 mg taken either 30 or 60 minutes before breakfast during 12 months treatment in patients with postmenopausal osteoporosis.
-
Protocol Number:
ML18056
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.09.2006
Phase:
IV
A prospective, open-label, multi-center, two-part study to investigate patient satisfaction with monthly dosed ibandronate therapy in women with postmenopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate.
-
Protocol Number:
ML18057
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.09.2006
Phase:
IV
A prospective, open-label, multicenter study to evaluate the change in bone turnover markers after once monthly oral ibandronate therapy in treatment naïve postmenopausal osteoporosis patients.
-
Protocol Number:
ML19913
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
26.03.2008
Phase:
IV
A randomised, open-label, multi national study to investigate the impact of bone marker feedback (at 2 months) on adherence to once-monthly ibandronate treatment for post-menopausal osteoporosis (PMO)
-
Protocol Number:
MM17385
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.05.2007
Phase:
III
A randomized, double-blind, double-dummy, parallel-group, multicenter study to compare the efficacy and safety of once monthly oral administration of 150mg ibandronate with once weekly oral administration of 70mg alendronate in postmenopausal osteoporosis - a non-inferiority tral.
-
Protocol Number:
MF4433
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.04.2002
Phase:
II
A single-center, randomized, parallel and cross-over, placebo-controlled study of the efficacy and safety of daily and intermittent ibandronate administration in the treatment of postmenopausal osteoporosis.
-
Protocol Number:
ML25399
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
To be Published
Phase:
III
A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis
-
Protocol Number:
ML22927
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
To be Published
Phase:
IV
A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis
-
Protocol Number:
MF4472
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.07.2001
Phase:
III
A two-center, randomized, comparative study using 2 mg intermittent iv ibandronate and 10 mg daily oral alendronate during 2 years in the treatment of post-menopausal osteoporosis.
-
Protocol Number:
MF4492
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.05.2002
Phase:
III
Double-blind, placebo-controlled, randomized, multicenter study of the efficacy and safety of ibandronate (BM 21.0955) during an extended two year partial crossover study of patients enrolled in MF 4380 (3-year post-menopausal osteoporosis treatment study) using an intermittent i.v. injection regimen of 0.5 mg and 1 mg every 3 months.
-
Protocol Number:
MF4380F
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.05.2002
Phase:
III
Double-blind, placebo-controlled, randomized, multicenter study on the efficacy and safety of ibandronate (BM 21.0955) during an extended two year parallel group study of patients enrolled in MF 4380 (3-year post-menopausal osteoporosis treatment study) using an intermittent i.v. injection regimen of 0.5 mg and 1 mg every 3 months.
-
Protocol Number:
MF4380
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.05.2002
Phase:
III
Efficacy and safety of long-term, intermittent iv ibandronate treatment in women with postmenopausal osteoporosis.
-
Protocol Number:
MF4411
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.05.2002
Phase:
III
Multicenter, double-blind, placebo-controlled, randomized study on the efficacy and safety of ibandronate over 3 years in patients with postmenopausal osteoporosis using a continuous oral and an intermittent oral dosing regimen.
-
Protocol Number:
MF4470
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.03.2002
Phase:
II
Multicenter, double-blind, placebo-controlled, randomized, dose-finding study on the efficacy and safety of ibandronate (BM 21.0955) during 2 years’ treatment in patients with postmenopausal osteoporosis using an intermittent (every 3 months) iv injection of 1 mg or 2 mg.
-
Protocol Number:
MF4376
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.09.2001
Phase:
II
Open, monocenter, pilot-study on the efficacy and safety of intermittent, intravenous administration of BM 21.0955 (2.0 mg every three months) during 2 years’ treatment in male patients with osteoporosis.
-
Protocol Number:
ML18373
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.06.2007
Phase:
III
Open-label, multicenter study to assess the persistance on treatment in women with postmenopausal osteoporosis receiving once-monthly ibandronic acid with either a patient support programme (PSP) or bone turnover marker monitoring (BM).
-
Protocol Number:
MF4375
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.08.2000
Phase:
II
Open-label, single-arm, multicenter study on the efficacy and safety of intermittent, intravenous administration if BM 21.0955 (2.0 mg every 3 months) during 12 months’ treatment of corticosteroid-induced osteoporosis.
-
Protocol Number:
MF4407
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.08.2000
Phase:
II
Open-label, single-arm, multicenter, follow-up study on the efficacy and safety of intermittent, intravenous administration of BM 21.0955 (1.0 mg every 3 months) during 3 years’ treatment of patients with post-menopausal osteoporosis.
-
Protocol Number:
ML18160
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.05.2006
Phase:
IV
Randomised, open-label, multi-centre, study designed to reflect routine clinical care in order to assess persistence on treatment in women with post-menopausal osteoporosis receiving once-monthly ibandronate with a patient support programme versus once-weekly alendronate.
-
Protocol Number:
BM16549
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
29.09.2005
Phase:
III
Randomized, Double-Blind, Double-Dummy, Parallel Groups, Multi-Center Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate with 2.5 mg Daily Oral Ibandronate in Post-Menopausal Osteoporosis; Year 2 Analysis
-
Protocol Number:
BP16331
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
20.10.2006
Phase:
II
Randomized, double-blind, placebo-controlled, multicentre, dose-ranging study to determine the tolerability and effect on bone turnover of several monthly doses of ibandronate in postmenopausal osteopenic and osteoporotic women.
-
Protocol Number:
MA17843
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
30.06.2005
Phase:
IV
Randomized, Open-Label, Multi-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once-Monthly Ibandronate and Once-Weekly Alendronate. A 6-Month, 2-Sequence, and 2-Period Crossover Study
-
Protocol Number:
MA17844
Product Name:
Bonviva/Boniva
[ibandronate]
Date of Report:
01.01.2006
Phase:
IV
Randomized, Open-Label, Multi-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once-Monthly Ibandronate and Once-Weekly Alendronate. A 6-Month, 2-Sequence, and 2-Period Crossover Study