Clinical trials: Postmenopausal Women With Osteoporosis
Postmenopausal Women With Osteoporosis
A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.
This was a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with…
- Trial name
- NCT05338086
- Testing
- MB09 (denosumab biosimilar), EU-Prolia, Elemental Calcium
- Where
- 64 sites in Bulgaria, Estonia and 6 more
- Volunteers
- 558 people
- Sponsor
- mAbxience Research S.L.
Postmenopausal Osteoporosis
A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.
- Trial name
- NCT02016716
- Testing
- Romosozumab 90 mg/mL, Romosozumab 70 mg/mL
- Where
- 12 sites in United States, Czechia and 1 more
- Volunteers
- 294 people
- Sponsor
- Amgen
Osteoporosis, Postmenopausal
Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
This was a prospective, randomized, open-label, two arm phase III trial designed to evaluate the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women with operable breast cancer who had received…
- Trial name
- NCT00332709
- Testing
- Letrozole, Zoledronic acid
- Where
- 23 sites in Germany
- Volunteers
- 83 people
- Sponsor
- Novartis
Postmenopausal Women With Osteoporosis
A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis
- Trial name
- NCT04757376
- Testing
- CT-P41, US-licensed Prolia
- Where
- 20 sites in Estonia, Latvia and 2 more
- Volunteers
- 479 people
- Sponsor
- Celltrion
Postmenopausal Osteoporosis
A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates
This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women.
- Trial name
- NCT00936897
- Testing
- Ibandronate, Denosumab
- Volunteers
- 833 people
- Sponsor
- Amgen
Postmenopausal Osteoporosis
A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis
This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.
- Trial name
- NCT04664959
- Testing
- SB16 (Proposed Denosumab Biosimilar), Prolia® (Denosumab)
- Where
- 5 sites in Poland
- Volunteers
- 457 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Post-Menopausal Osteoporosis
A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal…
- Trial name
- NCT00503113
- Testing
- ibandronate [Bonviva/Boniva], Alendronate
- Where
- 44 sites in United States, Argentina and 4 more
- Volunteers
- 801 people
- Sponsor
- Hoffmann-La Roche
Postmenopausal, Osteopenia
Effects of Denosumab on the Pharmacokinetics of Etanercept
The primary objective of the study was to characterize the effects of a single dose of denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone mineral density (BMD) and rheumatoid arthritis…
- Conditions
- Postmenopausal, Osteopenia, Rheumatoid Arthritis, Osteoporosis
- Trial name
- NCT01294397
- Testing
- Etanercept, Denosumab
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Amgen
Post-Menopausal Osteoporosis
BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.
This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis.
- Trial name
- NCT00545779
- Testing
- Ibandronate
- Where
- 32 sites in Albania, Bosnia and Herzegovina and 4 more
- Volunteers
- 677 people
- Sponsor
- Hoffmann-La Roche
Post-Menopausal Osteoporosis, Post-Menopausal Osteopenia
Vitamin K Supplementation in Post-Menopausal Osteopenia
The purpose of this study is to determine whether supplementation with 5 mg vitamin K daily over a 2-year period will prevent bone loss in post-menopausal women with osteopenia.
- Trial name
- NCT00150969
- Testing
- vitamin K1 (phylloquinone)
- Where
- 5 sites in Canada
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Post Menopausal Osteoporosis
Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when…
- Trial name
- NCT01674621
- Testing
- Abaloparatide Transdermal (50 mcg), Abaloparatide Transdermal (100 mcg), Abaloparatide Transdermal (150 mcg)
- Where
- 9 sites in United States, Denmark and 2 more
- Volunteers
- 250 people
- Sponsor
- Radius Health, Inc.
Post Menopausal Osteoporosis
A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)
This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated.
- Trial name
- NCT00303485
- Testing
- Vitamin D and calcium supplementation, ibandronate [Bonviva/Boniva]
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Osteoporosis, Postmenopausal
Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in…
- Trial name
- ALVOBOND (NCT05395091)
- Testing
- AVT03, Denosumab
- Where
- 34 sites in Bulgaria, Czechia and 3 more
- Volunteers
- 532 people
- Sponsor
- Alvotech Swiss AG
Osteoporosis, Postmenopausal
A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.
- Trial name
- NCT01495000
- Testing
- denosumab
- Where
- 11 sites in India
- Volunteers
- 250 people
- Sponsor
- GlaxoSmithKline
Post-Menopausal Osteoporosis
A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis
To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP)…
- Trial name
- NCT03432533
- Testing
- romosozumab HCP administration with PFS, romosozumab self-administration with AI/Pen
- Where
- 46 sites in United States, Poland and 1 more
- Volunteers
- 283 people
- Sponsor
- Amgen
Post Menopausal Osteoporosis
DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration.
- Trial name
- NCT00048074
- Testing
- ibandronate [Bonviva/Boniva]
- Where
- 64 sites in United States, Australia and 14 more
- Volunteers
- 1,395 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms, Osteoporosis
Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy
This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start (based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip…
- Trial name
- NCT00050011
- Testing
- Zoledronic Acid, Letrozole
- Where
- 44 sites in United States, Puerto Rico
- Volunteers
- 602 people
- Sponsor
- Novartis Pharmaceuticals
Low Bone Mineral Density
Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density
To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD.
- Trial name
- NCT00043186
- Testing
- Denosumab, Alendronate
- Volunteers
- 412 people
- Sponsor
- Amgen
Postmenopausal Women With Osteoporosis
Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis
This is a randomized, double-blind, multicenter, parallel-arm, Phase 3 study to compare the efficacy, PK (Pharmacokinetic), PD (Pharmacodynamic), safety, and immunogenicity of Bmab 1000 and Prolia® in postmenopausal women with…
- Trial name
- DEVOTE (NCT05345691)
- Testing
- Bmab 1000, Prolia®
- Where
- United Kingdom
- Volunteers
- 479 people
- Sponsor
- Biocon Biologics UK Ltd
Osteoporosis
Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis
A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis
- Trial name
- NCT00489918
- Testing
- teriparatide
- Volunteers
- 165 people
- Sponsor
- Zosano Pharma Corporation