Status:
COMPLETED
2-Year Therapy With Teriparatide vs 1-yr Therapy Followed by 1-Year of Raloxifene or Calcium/Vit D in Severe Postmenopausal Osteoporosis
Lead Sponsor:
Eli Lilly and Company
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
55+ years
Phase:
PHASE4
Brief Summary
The primary purpose of the study is to compare 3 different osteoporosis therapies following one year of teriparatide.In the first year,all eligible patients received open-label teriparatide 20 microgr...
Eligibility Criteria
Inclusion
- Ambulatory women greater or equal to 55 years, at least 2 years postmenopausal.
- Lumbar spine or total hip or femoral neck bone mineral density measurement must be at least 2.5 standard deviations (SD) below the average bone mass for young women (T-score -2.5 or less).
- Presence of at least one known and documented preexisting clinical fragility fracture, in the past 3 years.
- Patients may be included in substudy 2 if they meet any one of the following additional criteria - Patients who have sustained at least one new fragility fracture (vertebral or nonvertebral), despite prescription of antiresorptive therapy\* during the 12 months prior to the last new fracture or patients who, after a minimum of two years after initiating antiresorptive therapy\*, either have a lumbar spine, femoral neck, or total hip BMD of at least - 3SD below the average bone mass for young women (T-score -3 or less), or who show a decrease of at least 3.5% in BMD at any one of these sites.
- \*Antiresorptive therapy includes all bisphosphonates, raloxifene, ERT/HRT, calcitonin, and vitamin D metabolites.
Exclusion
- For substudy 1 patients only:
- current or history of vaginal bleeding or spotting of unknown cause in the 1 year prior to study start
- currently suspected or history of venous thrombotic events (VTE), including lower extremity thrombosis, and other major venous thromboses, or high risk of developing VTE as assessment by the investigator.
- Treatment with
- Vitamin D \>50,000 IU/week or with any dose of calcitriol or vitamin D analogs or agonists in the 6 months prior to visit 2
- Fluorides in the 12 months prior to visit 2.
- Systemic corticosteroids (other than for replacement therapy) in the 1 month prior to visit 2.(Ophthalmic, otic topical, orally inhaled, nasally inhaled, or intra-articular corticosteroid therapy may be used without these restrictions.)
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
810 Patients enrolled
Trial Details
Trial ID
NCT00191425
Start Date
August 1 2002
End Date
November 1 2005
Last Update
July 16 2007
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bad Pyrmont, Germany, D-31812