Treatment Trials

176 Clinical Trials for Various Conditions

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A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia
Description

This study will investigate participant satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on study treatment is 6 months, and the target sample size is 1776 individuals.

Conditions

Postmenopausal Osteoporosis

A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
Description

This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.

Conditions

Post Menopausal Osteoporosis

A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis
Description

This study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 individuals.

Conditions

Postmenopausal Osteoporosis

Role of T-cells in Post-Menopausal Osteoporosis
Description

This is an observational study of women undergoing surgical menopause to determine whether T-cells play an important role in the etiology of post-menopausal osteoporosis. Subjects will examined before and after surgery and followed over a two year period to determine the biology of T-cells during this study period.

Conditions

Osteoporosis

A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
Description

This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.

Conditions

Post-Menopausal Osteoporosis

A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
Description

This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions

Post Menopausal Osteoporosis

A Study to Assess the Safety and Efficacy of 3 Doses of ALX1-11 (50, 75, and 100µg) in the Treatment of Postmenopausal Osteoporosis
Description

A double-blind, placebo-controlled, parallel-group study to assess the safety and efficacy of 3 doses of ALX1-11 (recombinant human parathyroid hormone \[rhPTH(1-84)\])(50, 75 and 100 µg) in the treatment of postmenopausal osteoporosis. The primary objective of this study is to compare the efficacy of ALX1-11 (50, 75 and 100 µg) with that of placebo in terms of increasing vertebral bone mineral density, when given daily by subcutaneous injection for 12 months in postmenopausal women with osteoporosis.

Conditions

Osteoporosis

TOP: Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis
Description

This is an 18-month, double-blind, placebo-controlled, Phase III trial with a 12-month interim analysis of the effect of ALX1-11, recombinant human parathyroid hormone (1-84) (rhPTH \[1-84\]), on fracture incidence in women with postmenopausal osteoporosis, the TOP study.

Conditions

Osteoporosis

A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva
Description

This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Conditions

Post-Menopausal Osteoporosis

DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
Description

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. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Conditions

Post Menopausal Osteoporosis

MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
Description

This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Conditions

Post Menopausal Osteoporosis

Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
Description

The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.

Conditions

Menopause, Osteoporosis

Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
Description

This study will be conducted to assess the efficacy, pharmacodynamic (PD), safety, tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia® in participants with postmenopausal osteoporosis, in a comparative manner.

Conditions

Postmenopausal Osteoporosis

Anabolic Therapy in Postmenopausal Osteoporosis
Description

In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.

Conditions

Postmenopausal Osteoporosis

A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
Description

The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)

Conditions

Osteoporosis, Postmenopausal

Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis
Description

This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab).

Conditions

Postmenopausal Women With Osteoporosis

A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis
Description

The primary purpose of this study was to evaluate the efficacy of oral calcitonin (rsCT)tablets in the prevention of bone loss in postmenopausal women with lower bone mineral density at increased risk of fracture. The secondary purpose of this study was to determine if there is any food effect by comparing the efficacy and safety of oral calcitonin tablets administered at dinner or at bedtime.

Conditions

Osteopenia

µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis
Description

The purpose of this study is to apply a novel advanced magnetic resonance imaging methodology to evaluate the response to drug intervention involving two treatment arms of postmenopausal participants with osteoporosis, randomized into either a teriparatide (Forteo™) or zoledronic acid (Reclast™) group.

Conditions

Osteoporosis, Osteopenia

Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
Description

The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one alone in postmenopausal osteoporotic women.

Conditions

Osteoporosis

Texture Analysis for Postmenopausal Osteoporosis
Description

The purpose of this study is to determine if a new test for osteoporosis can be useful in monitoring treatment. We are studying a new method for examining the quality of bone by an experimental method of computerized analysis of radiographic images (x-ray pictures) of the heel.

Conditions

Osteoporosis, Osteopenia

Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)
Description

This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.

Conditions

Osteoporosis

Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes
Description

The goal of this clinical trial is to learn if romosozumab (Evenity) can improve bone and muscle health in postmenopausal women with osteoporosis who are undergoing lumbar spine surgery. The main questions it aims to answer are: * Does romosozumab improve bone strength and reduce the risk of complications during and after spine surgery? * Does romosozumab increase muscle mass and help patients recover better from surgery? Researchers will compare romosozumab (a monthly injection) to alendronate (a weekly pill), both approved treatments for osteoporosis, to see which is more effective in this surgical setting. Participants will: * Be randomly assigned to receive romosozumab or alendronate * Take standard vitamin supplements and receive a one-time dose of zoledronic acid near the end of the study * Attend five study visits over about 12 months * Undergo bone scans, muscle imaging, and complete health questionnaires before and after surgery

Conditions

Osteoporosis, Post-menopausal

A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis
Description

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) administration with prefilled syringe (PFS) or by subject self-administration with autoinjector/pen (AI/Pen)

Conditions

Post-Menopausal Osteoporosis

A Study of 2 Different Formulations of Blosozumab (LY2541546) in Post Menopausal Women
Description

The purpose of this study is to evaluate the tolerability of two different formulations of blosozumab in women who have reached menopause. This study will last approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to starting the study.

Conditions

Osteoporosis, Postmenopausal

Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
Description

This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.

Conditions

Post Menopausal Osteoporosis

Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis
Description

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 compared to transdermal placebo and abaloparatide injection for 6 months of treatment.

Conditions

Post Menopausal Osteoporosis

3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs
Description

This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis

Conditions

Post-menopausal Osteoporosis

Long Term Effects of Raloxifene Treatment on Bone Quality
Description

This is a cross-sectional study to determine, via iliac crest bone biopsies, the effect of long-term treatment with raloxifene on histomorphometry and bone quality in patients who participated in the Continuing Outcomes Relevant to Evista Study.

Conditions

Osteoporosis, Post-Menopausal

Carotid Artery Intima-Media Thickness Following Exposure to Raloxifene or Placebo
Description

The purpose of this study is to measure carotid artery IMT at a single visit in a subset of women previously enrolled in the CORE (H3S-MC-GGJY) trial

Conditions

Osteoporosis, Post-Menopausal

A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
Description

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 disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Conditions

Post-Menopausal Osteoporosis