DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



PTH Comparison in Post Menopausal Women

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis, Post-Menopausal

Intervention: teriparatide 20 micrograms/day subcutaneous (Drug); calcitonin 100 IU/day subcutaneous (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

Summary

Compare in postmenopausal women with established osteoporosis the effect of treatment with teriparatide 20 micrograms/day subcutaneous with the effect of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD.

Clinical Details

Official title: Comparison of Teriparatide and Calcitonin in the Treatment of Postmenopausal Women With Osteoporosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To compare in postmenopausal women with established osteoporosis the effect of treatment with teriparatide 20 micrograms/day subcutaneous with the effect of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD.

Secondary outcome:

To compare in postmenopausal women with established osteoporosis the effect of treatment with teriparatide 20 micrograms/day with the effect of calcitonin 100 IU/day on change in femoral neck and total hip BMD

Compare the effect of teriparatide 20 micrograms/day with calcitonin 100 IU/day on change in biochemical bone markers (bone specific alkaline phosphatase[BSAP] and Osteocalcin) at 3 and 6 months after treatment with teriparatide versus calcitonin

Safety as determined by physical examinations, vital signs, clinical labs and reports of adverse events

Eligibility

Minimum age: 55 Years. Maximum age: 85 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Ambulatory, postmenopausal women aged 55-85 years (at least 3 years have elapsed

after menopausal) are included at the time of entry into the trial. They have to be free of severe or chronically disabling conditions other than osteoporosis.

- The patient should have a documented (X-ray) prevalent osteoporotic vertebral

fracture (defined as 3. 4) or non vertebral fragility fracture (excluding major trauma).

- L-1 through L-4 vertebrae must be without artifacts, multiple vertebral fractures;

therefore at least 3 vertebrae should be without fractures, osteophytes, or other abnormalities that would interfere with the analysis of the posterior-anterior lumbar

spine BMD measurement. The reading of the BMD, T-score should be in the range of -

2. 0 and - 4. 0 at least for one of the 2 sites measured (spine or hip).

The initial lumbar spine and femoral neck BMD assessment and the determination of the patient's eligibility for entry into the screening phase will be made by the central quality assurance for BMD. The central quality assurance center will determine the patient's eligibility for enrollment into the treatment phase. If the L-1 vertebra cannot be analyzed due to artifacts, vertebral fracture, osteophytes, or other abnormalities, that vertebra should be excluded from the analysis.

- Women without language barrier, cooperative expected to return for all follow-up

procedures and who have given informed consent before entering the study and after being informed of the risks, medications, and procedures to be used in the study.

- Normal or clinically insignificant abnormal laboratory values including serum

calcium, PTH(1-84) levels and alkaline phosphatase. Exclusion Criteria:

- History of diseases which affect bone metabolism other than postmenopausal

osteoporosis such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.

- Patients who have an increased baseline risk of osteosarcoma: Paget's disease of the

bone or unexplained elevations of alkaline phosphatase; Children and young adult with open epiphyses; Patients who have received radiation therapy involving the skeleton.

- History of other malignant neoplasms in the 5 years prior to screening, with the

exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may enter the study.

- History of nephrolithiasis or urolithiasis in the 2 years prior to Visit 2. Patients

with any history of nephro- or urolithiasis must have an appropriate radiology study within 6 months prior to Visit 2. This radiology study, such as an intravenous pyelogram or a supine radiograph of the kidney-ureter-bladder, must document the absence of active disease.

- History of sprue, inflammatory bowel disease, or malabsorption syndrome in the 1 year

prior to Visit 2.

Locations and Contacts

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) Mon-Fri from 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Changhua, Taiwan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) Mon-Fri from 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Niao Sung Hsiang, Taiwan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) Mon-Fri from 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Taipei, Taiwan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559) Mon-Fri from 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Tao-Yuan, Taiwan

Additional Information

Lilly Clinical Trial Registry

Starting date: December 2002
Last updated: October 10, 2007

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017