Phase 3 N=7,808 A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
Osteoporosis
Primary: Number of Participants With New Vertebral Fractures — 264; 86 Participants — p=<0.0001
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=80 Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women
Postmenopausal Osteoporosis · Osteoporosis
Primary: Changes in Indices of Bone Turnover — 4418; 3696; 956; 822 months*(ng/ml - baseline ng/ml)
Phase 4 N=53 Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women
Osteopenia · Osteoporosis
Primary: Mean % Change From Baseline in Trabecular Number (Tb.N) by HR-pQCT — 2.1; -0.6; 0.9; 4.1 Percent change
Phase 3 N=407 Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
Osteoporosis
Primary: Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III. — 1.002; 0.990 Percentage Change — p=0.010
Phase 2 N=165 Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis
Osteoporosis
Primary: Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24 — -0.33; 2.96; 3.47; 4.97 percent change
Phase 2 N=399 A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004)
Osteoporosis
Primary: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months — -0.13; -0.62; 1.50; 2.65 Percentage change — p=<=0.001
Phase 3 N=7,609 Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
Osteoporosis
Primary: Percentage of Participants With New Vertebral Fractures Through Month 36 — 1.98; 2.14; 1.84; 3.13 Percentage of participants — p=0.22
Phase 3 N=240 Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women
Postmenopausal Osteoporosis
Primary: Bone Mineral Density BMD (Percentage) Change in Lumber Spine After 12 Months — 1.22; 2.17 percentage of BMD — p=0.26
Phase 4 N=33 µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis
Osteoporosis, Osteopenia
Primary: Percentage of Change in Trabecular Surface-to-curve Ratio — 9.1; 7.1 Percentage of Change
Phase 4 N=69 Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis
Osteoporosis
Primary: Change From Baseline to 3 Months in Mineralizing Surface (MS) /Bone Surface (BS) in the Cancellous Compartment (CC) of the Iliac Crest Bone Biopsies — 12.43; -2.51…
Phase 3 N=332 Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
Postmenopausal Osteoporosis
Primary: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 — 6.5; -.6 Percent Change from Baseline — p=<0.0001
Phase 4 N=109 Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy
Bone Loss · Osteoporosis · Breast Cancer
Primary: BMD of Spine by DXA — 2.269; -1.735 percentage change
Phase 3 N=200 An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Low Bone Mineral Density
Primary: Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 — 8.4; 11.2; 11.0; 16.5 percent
Phase 2 N=94 Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
Osteoporosis
Primary: Change in Spine Bone Density From Baseline to 2 Years — 8.3; 9.5; 12.9 percent change
Phase 2 N=419 Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density
Low Bone Mineral Density · Postmenopausal Osteoporosis
Primary: Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine — -0.1; 4.1; 7.1; 5.4 percent change — p=< 0.0001
Phase 2 N=412 Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density
Low Bone Mineral Density
Primary: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms — -0.81; 4.41; 4.71; 6.69 Percent change — p=<0.001
Phase 4 N=343 Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)
Osteoporosis Postmenopausal
Primary: Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment — 2; 55; 134; 77 participants — p=<0.0001
Phase 3 N=484 Denosumab China Phase III Study
Osteoporosis, Postmenopausal
Primary: Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12 — 5.22; 0.79 Percentage change — p=<0.0001
N/A N=142 99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis
Differentiated Thyroid Cancer · Osteoporosis
Primary: Percent Change of Bone Mineral Density in Lumbar and Hip — 3.0; 3.2; 3.8; 5.1 percentage change
Phase 3 N=250 A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
Osteoporosis, Postmenopausal
Primary: Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 6 — 4.26; 1.20 percent change — p=<0.0001
N/A N=1,501 Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis
Postmenopausal Osteoporosis
Primary: Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months — 92.2; 89.3; 94.3; 95.7 percentage of participants
Phase 3 N=1,083 Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women
Endometrial Hyperplasia · Osteoporosis
Primary: Percentage of Participants With Hyperplasia at Screening
Phase 3 N=7,180 Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
Postmenopausal Osteoporosis
Primary: Percentage of Participants With New Vertebral Fracture Through Month 12 — 1.8; 0.5 percentage of participants — p=< 0.001
Phase 3 N=22 Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women
Menopause · Fracture · Osteoporosis
Primary: Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA) — 10.8 percentage of BMD change
Phase 3 N=224 Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older
Osteopenia
Primary: Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum — 4.62; 4.03; -2.24; 5.60 Percentage change in BMD
Phase 3 N=2,463 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
Osteoporosis · Postmenopausal Osteoporosis
Primary: Number of Participants With New Vertebral Fractures at 18 Months — 30; 4; 6 participants — p=<0.0001
Phase 1 N=19 Melatonin Osteoporosis Prevention Study
Osteoporosis · Osteopenia
Primary: The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Serum Osteocalcin (OC) Levels in Women After 6 Months, as Compared to Baseline — -0.6; 1.83 ng/mL
Phase 4 N=69 Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women
Osteoporosis, Post-menopausal
Primary: Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months — 5.60; 0.16 percentage of surface — p=<0.001
Phase 3 N=532 Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND
Osteoporosis, Postmenopausal
Primary: Percent Change From Baseline in LS BMD at Month 12 to Demonstrate Comparable Efficacy of AVT03 and Prolia®. — 5.3; 5.18 Percent Change From Baseline in LS BMD
Phase 3 N=29 Secondary Prevention of Osteoporosis
Osteoporosis
Primary: Number Adherent With the Intervention — 29 participants