Postmenopausal Osteoporosis
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CLINICAL_TRIALS trial_result · 2016-10-28Clinical Trial Update: BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy. [Phase 3]
This Clinical Trial Update describes the Phase 3 BONCURE study of monthly Bonviva (ibandronate) in women with postmenopausal osteoporosis on…
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CLINICAL_TRIALS trial_result · 2016-10-24Clinical Trial Update: A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP) [Phase 4]
A Phase 4 clinical trial updates adherence to a once-monthly ibandronate regimen (Bonviva) in women with postmenopausal osteoporosis, with r…
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FDA approval · 2016-10-12FDA Approved: RALOXIFENE HYDROCHLORIDE — Original Application (ScieGen Pharmaceuticals Inc)
FDA approves the original application for raloxifene hydrochloride from ScieGen Pharmaceuticals Inc, providing a generic option for postmeno…
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CLINICAL_TRIALS research · 2016-09-30Clinical Trial Update: A 5-Year Follow-up Study Investigating Factors Associated With Osteoporotic Fracture in Chinese Postmenopausal Women [NA]
This is a completed five-year follow-up clinical study from Peking Union Medical College Hospital examining factors associated with osteopor…
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CLINICAL_TRIALS trial_result · 2016-09-20Clinical Trial Update: Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis
Observational study update of denosumab (Prolia) in postmenopausal osteoporosis; study completed with results posted in 2016.
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CLINICAL_TRIALS trial_result · 2016-08-23Clinical Trial Update: A Study to Determine the Patient Preference Between Zosano Pharma Parathyroid Hormone (ZP-PTH) Patch and Forteo Pen [Phase 1]
Phase 1 study comparing patient preference between ZP-PTH Patch and Forteo Pen in postmenopausal osteoporosis has completed.
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FDA approval · 2016-08-18FDA Approved: ZOLEDRONIC ACID — Original Application (Fresenius Kabi USA, LLC)
FDA approved an Original Application for Zoledronic acid as a generic injectable product from Fresenius Kabi USA, LLC. The approval covers i…
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CLINICAL_TRIALS trial_result · 2016-07-29Clinical Trial Update: Proof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005) [Phase 2]
A Phase 2 proof-of-concept trial evaluating bone resorption and bone mineral density in postmenopausal osteoporosis has completed.
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CLINICAL_TRIALS trial_result · 2016-07-11Clinical Trial Update: The Effect of Mechanical Loading on Bone Material Strength and Microarchitecture in Postmenopausal Women [NA]
A completed clinical trial evaluated the effects of mechanical loading on bone material strength and microarchitecture in postmenopausal wom…
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CLINICAL_TRIALS trial_result · 2016-06-22Clinical Trial Update: Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis [Phase 4]
Phase 4 clinical trial update examining changes in gingival crevicular fluid levels of RANKL and osteoprotegerin in patients with chronic pe…
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CLINICAL_TRIALS trial_result · 2016-05-30Clinical Trial Update: MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis [Phase 3]
The MOBILE study, a Phase 3 trial evaluating regimens of Bonviva (ibandronate) in postmenopausal osteoporosis, has completed with results po…
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FDA approval · 2016-05-24FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for RECLAST (zoledronic acid) submitted by Sandoz Inc. The approval updates the product's labeli…
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CLINICAL_TRIALS trial_result · 2016-05-12Clinical Trial Update: A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis. [Phase 4]
Phase 4 trial evaluating once-monthly ibandronate (Bonviva) for prevention of glucocorticoid-induced osteoporosis has completed, with result…
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FDA approval · 2016-05-04FDA Approved: PREMPRO — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application for PREMPRO, a combination of conjugated estrogens and medroxyprogesterone acetate, from Wyeth P…
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CLINICAL_TRIALS trial_result · 2016-05-02Clinical Trial Update: A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate) [Phase 4]
A Phase 4 study assessed bone turnover markers in postmenopausal women with osteoporosis treated with monthly ibandronate (Boniva).
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FDA approval · 2016-03-29FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental application for alendronate sodium from Amneal Pharmaceuticals of New York LLC. This action indicates regula…
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FDA approval · 2016-03-22FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)
The FDA approved a supplemental application for Binosto (alendronate sodium) from Radius Health, Inc., updating the product labeling as part…
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FDA approval · 2016-03-22FDA Approved: RALOXIFENE HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approves Glenmark's original application for raloxifene hydrochloride (generic) for postmenopausal osteoporosis and for reducing the ris…
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FDA approval · 2016-03-11FDA Approved: IBANDRONATE SODIUM — Original Application (Aurobindo Pharma Limited)
FDA approves an Original Application for ibandronate sodium as a generic product (Aurobindo Pharma Limited), enabling its use for osteoporos…
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CLINICAL_TRIALS trial_result · 2016-03-09Clinical Trial Update: A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis [Phase 4]
Phase 4 trial evaluating bone turnover markers in treatment-naive postmenopausal osteoporosis patients treated with ibandronate (Boniva); re…
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CLINICAL_TRIALS trial_result · 2016-03-04Clinical Trial Update: Intra-venous Zoledronic Acid Once Yearly
This document notes the completion of a clinical trial evaluating annual intravenous zoledronic acid for postmenopausal osteoporosis.
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FDA approval · 2016-02-25FDA Approved: PREMPRO — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application for PREMPRO (conjugated estrogens and medroxyprogesterone acetate) from Wyeth Pharmaceuticals (Pfize…
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CLINICAL_TRIALS trial_result · 2016-02-03Clinical Trial Update: DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis [Phase 3]
Phase 3 DIVA study evaluating different intravenous regimens of ibandronate (Bonviva) for postmenopausal osteoporosis; the trial completed a…
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CLINICAL_TRIALS trial_result · 2016-02-02Clinical Trial Update: Osteoporosis Choice Decision Aid for Use of Bisphosphonates in Postmenopausal Women [NA]
A completed Mayo Clinic–sponsored trial evaluating an osteoporosis decision aid to help postmenopausal women decide whether to use bisphosph…
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CLINICAL_TRIALS trial_result · 2016-01-25Clinical Trial Update: Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis [Phase 4]
Phase 4 trial comparing denosumab with zoledronic acid in postmenopausal osteoporosis completed with posted results.