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Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis

NCT00670501•Eli Lilly and Company

Summary

The primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and vitamin D alone.

Eligibility

Age

30 - 85 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Ambulatory, postmenopausal women.
•A minimum of either one moderate or two mild atraumatic vertebral fractures, and a minimum of seven evaluable nonfractured vertebrae.
•Hip BMD or lumbar spine BMD measurement at least 1.0 standard deviation (SD) below the average bone mass for young, healthy women (T-score) only in patients with fewer than two moderate fractures or in patients previously treated with therapeutic doses of bisphosphonates or fluorides
•Normal or clinically nonsignificant abnormal laboratory values (serum calcium, PTH(1-84), \& urine calcium must be within normal limits at baseline; 25-hydroxyvitamin D must be between the lower limit of normal \& 3 times the upper limit of normal at baseline).

Exclusion Criteria

•Fractures in areas of bone affected by diseases other than osteoporosis (for example, cancer or Paget's disease).
•Satisfactory baseline thoracic and lumbar spinal x-ray views cannot be obtained as determined by the centralized x-ray quality assurance center (for example, severe scoliosis or kyphosis).
•Current or recent (within 1 year prior to randomization) metabolic bone disorders other than postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia, or any secondary causes of osteoporosis
•Current or recent (within 1 year prior to randomization) disease which affects bone metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.
•Currently suspected carcinoma or history of carcinoma in the 5 years prior to randomization.
•Nephrolithiasis or urolithiasis in the 2 years prior to randomization.
•Current or recent (within 1 year prior to randomization) sprue, inflammatory bowel disease, or malabsorption syndrome, or any indication of poor intestinal absorption of calcium, such as the combination of a low urinary calcium excretion and an elevated serum intact parathyroid hormone level.
•Poor medical or psychiatric risk for treatment with an investigational drug, in the opinion of the investigator.
•Treatment with androgens or other anabolic steroids in the 6 months prior to randomization.
•Treatment with calcitonins in the 2 months prior to randomization.
+10 more criteria

Locations (17)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Boston, Massachusetts, United States

Capital Federal, Argentina

Nedlands, Australia

Graz, Austria

Brussels, Belgium

Calgary, Alberta, Canada

Prague, Czechia

Aarhus, Denmark

Kuopio, Finland

Szeged, Hungary

Key Dates

Start Date

August 1, 1996

Primary Completion Date

April 1, 1999

Completion Date

April 1, 1999

Last Updated

May 1, 2008

Enrollment

1,637

ACTUAL participants

Conditions

Osteoporosis, Postmenopausal

Interventions

teriparatide

DRUG

teriparatide

DRUG

Placebo

DRUG

Calcium Supplement

DRUG

Vitamin D Supplement

DRUG

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

NCT05575167

Osteoporosis, Postmenopausal

View study

RECRUITINGNA

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

NCT05228262

Osteoporosis, Postmenopausal

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WITHDRAWNPHASE4

Effect of Mechanical Loading With PTH on Cortical Bone

NCT03232476

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 1, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

Inclusion Criteria

Exclusion Criteria

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

Effect of Mechanical Loading With PTH on Cortical Bone

A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

Efficacy and Safety of MW031 in PMO Subjects