PTH Comparison in Post Menopausal Women

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00543218
First received: October 10, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Osteoporosis, Post-Menopausal
Drug: teriparatide 20 micrograms/day subcutaneous
Drug: calcitonin 100 IU/day subcutaneous
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Teriparatide and Calcitonin in the Treatment of Postmenopausal Women With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 Measures:
  • 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

Enrollment: 63
Study Start Date: December 2002
Study Completion Date: June 2004
Arms Assigned Interventions
Active Comparator: A
teriparatide 20 micrograms/day subcutaneous
Drug: teriparatide 20 micrograms/day subcutaneous
Other Name: LY333334
Active Comparator: B Drug: calcitonin 100 IU/day subcutaneous

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543218

Locations
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
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00543218     History of Changes
Other Study ID Numbers: 6573, B3D-TW-GHCB
Study First Received: October 10, 2007
Last Updated: October 10, 2007
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Salmon calcitonin
Calcitonin
Teriparatide
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014