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About This Section
Access a regularly updated listing of late-stage clinical trials of high relevance to clinicians who provide care to patients who have or are at risk for osteoporosis. Featured in the most recent update are studies on postmenopausal osteoporosis, secondary osteoporosis, osteoporosis in men, hip and vertebral fracture prevention, and therapeutic agents such as bisphosphonates, calcitonin, denosumab, estrogen, odanacatib, parathyroid hormone analogs, estrogen receptor agonists/antagonists, and other drugs in development.
Hormone Therapy
Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes
Conditions: Amenorrhea; Female Athlete Triad Syndrome
Interventions: Drug: Transdermal 17Beta-estradiol, progesterone; Drug: Ethinyl Estradiol + Desogestrel; Dietary Supplement: Elemental Calcium and Vitamin D
Sponsors: Massachusetts General Hospital; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Recruiting - verified March 2010
Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
Conditions: Menopause; Osteoporosis
Interventions: Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg; Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg; Drug: bazedoxifene 20 mg; Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg; Drug: Placebo
Sponsor: Wyeth
Active, not recruiting - verified September 2010
Efficacy and Safety of Estradiol and Progesterone Microspheres for the Treatment of Climacteric Symptoms.
Condition: Menopause
Interventions: Drug: Estradiol and Progesterone; Drug: Estradiol and Progesterone
Sponsor: Centro A.F. de Estudios Tecnologicos, S.A.
Completed - verified August 2009
Tibolone Endometrium Study (Study 32972)(COMPLETED)
Condition: Postmenopausal Women
Interventions: Drug: tibolone; Drug: Tibolone 2.5 mg; Drug: CE/MPA
Sponsor: Schering-Plough
Completed - verified October 2009
Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
Conditions: Endometrial Hyperplasia; Osteoporosis
Interventions: Drug: Bazedoxifene/Conjugate Estrogens (CE); Drug: Raloxifene; Drug: Placebo
Sponsor: Wyeth
Completed - verified May 2008
Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis
Condition: Osteoporosis, Postmenopausal
Interventions: Drug: Raloxifene HCL; Drug: Raloxifene HCL; Drug: Placebo
Sponsor: Eli Lilly and Company
Completed - verified April 2008
Trial to Evaluate Tibolone in the Treatment of Osteoporosis (COMPLETED)(Study 32962)
Condition: Osteoporosis
Interventions: Drug: Tibolone; Drug: Placebo
Sponsor: Schering-Plough
Completed - verified October 2009
A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis
Condition: Osteoporosis, Postmenopausal
Interventions: Drug: MK0217, /Duration of Treatment : 12 Months; Drug: Comparator : raloxifene hydrochloride /Duration of Treatment : 12 Months
Sponsor: Merck
Completed - verified September 2008
Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis
Condition: Osteoporosis, Postmenopausal
Interventions: Drug: Arzoxifene; Drug: Raloxifene
Sponsor: Eli Lilly and Company
Completed - verified January 2010
Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women
Conditions: Menopause; Osteopenia
Intervention: Drug: Genistein
Sponsor: University of Messina
Completed - verified April 2008
A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss
Condition: Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women
Intervention: Drug: Zoledronic Acid
Sponsor: Novartis
Recruiting - verified November 2009
Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa
Condition: Anorexia Nervosa
Intervention: Drug: DHEA + Hormone replacement therapy (estrogen/progestin)
Sponsors: Children's Hospital Boston; Department of Defense; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Active, not recruiting - verified July 2008
3-Year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-Menopausal Women
Condition: Osteopenia
Interventions: Drug: Menostar (Estradiol, BAY86-5435); Drug: Raloxifene
Sponsor: Bayer
Completed - verified July 2009
Study Evaluating Bazedoxifene Acetate in Osteoporosis
Condition: Osteoporosis
Interventions: Drug: Bazedoxifene Acetate; Drug: Raloxifene; Other: Placebo
Sponsor: Wyeth
Active, not recruiting - verified May 2010
Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss
Condition: Osteoporosis
Interventions: Drug: lasofoxifene; Drug: raloxifene; Drug: placebo
Sponsor: Pfizer
Completed - verified March 2006
Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy
Conditions: Prostate Cancer; Osteoporosis; Fractures
Intervention: Drug: Toremifene Citrate
Sponsor: GTx
Completed - verified December 2008
Zoledronate in Preventing Bone Loss in Postmenopausal Women Who Are Receiving Letrozole for Stage I, Stage II, or Stage IIIA Breast Cancer
Conditions: Breast Cancer; Osteoporosis
Interventions: Drug: letrozole; Drug: zoledronic acid; Procedure: adjuvant therapy
Sponsors: North Central Cancer Treatment Group; National Cancer Institute (NCI)
Active, not recruiting - verified March 2006
Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms
Conditions: Menopause; Osteoporosis; Osteopenia
Interventions: Dietary Supplement: Soy isoflavones; Dietary Supplement: Placebo
Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Active, not recruiting - verified April 2009
Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
Condition: Alzheimer Disease
Intervention: Drug: Raloxifene
Sponsor: University of Wisconsin, Madison
Completed - verified March 2006
Vitamin K and Bone Turnover in Postmenopausal Women
Condition: Osteoporosis
Interventions: Drug: phylloquinone (K1); Drug: menatetranone (MK4)
Sponsors: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Eisai Limited
Completed - verified March 2010
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
Conditions: Breast Neoplasms; Osteoporosis
Intervention: Drug: Zoledronic Acid and Letrozole
Sponsor: Novartis Pharmaceuticals
Completed - verified May 2010
Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis
Condition: Osteoporosis, Postmenopausal
Interventions: Drug: teriparatide; Drug: raloxifene; Drug: placebo
Sponsor: Eli Lilly and Company
Completed - verified July 2006
Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer
Conditions: Osteoporosis; Prostate Cancer
Interventions: Dietary Supplement: calcium carbonate; Dietary Supplement: cholecalciferol; Drug: conjugated estrogens; Drug: risedronate sodium
Sponsors: North Central Cancer Treatment Group; National Cancer Institute (NCI)
Completed - verified January 2007
Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss
Condition: Osteoporosis
Interventions: Drug: conjugated estrogens; Drug: Medroxyprogesterone
Sponsors: National Institute of Dental and Craniofacial Research (NIDCR); Washington University School of Medicine
Completed - verified June 1999
Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis
Conditions: Osteopenia; Osteoporosis
Interventions: Drug: Alendronate; Drug: Estrogen/progestin therapy
Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Terminated - verified February 2004
Safety of Estrogens in Lupus: Hormone Replacement Therapy
Condition: Systemic Lupus Erythematosus
Intervention: Drug: Premarin and Provera
Sponsors: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Office of Research on Women's Health (ORWH)
Terminated - verified October 2002
Postmenopausal Estrogen/Progestin Interventions (PEPI)
Conditions: Bone Diseases; Cardiovascular Diseases; Coronary Disease; Diabetes Mellitus; Heart Diseases; Hypercholesterolemia; Hypertension; Myocardial Ischemia; Osteoporosis; Thrombosis; Postmenopause
Interventions: Drug: estrogens, conjugated; Drug: medroxyprogesterone; Drug: progesterone; Drug: estrogen replacement therapy
Sponsors: National Heart, Lung, and Blood Institute (NHLBI); National Institute on Aging (NIA); National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Completed - verified July 2005
Women's Health Initiative (WHI)
Conditions: Bone Diseases; Breast Neoplasms; Cardiovascular Diseases; Colonic Neoplasms; Coronary Disease; Heart Diseases; Myocardial Ischemia; Osteoporosis; Postmenopause
Interventions: Drug: hormone replacement therapy; Drug: estrogens; Drug: progestins; Drug: estrogen replacement therapy; Behavioral: diet, fat-restricted; Drug: calcium; Drug: vitamin D; Behavioral: dietary supplements
Sponsors: National Heart, Lung, and Blood Institute (NHLBI); National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); National Cancer Institute (NCI); National Institute on Aging (NIA)
Completed - verified January 2006
