A Study for Teriparatide in Severe Osteoporosis
- Registration Number
- NCT00696644
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This observational study will evaluate the incidence of new vertebral and non vertebral fragility fractures in patients with severe osteoporosis treated with anabolic drugs. This study will also evaluate BMD, compliance to treatment, back pain and the health-related quality of life.
- Detailed Description
The participants should be treated with anabolic therapy for osteoporosis (Teriparatide or PTH 1-84) for 18 months and should be followed up for subsequent 6 months. The treatment is expected to improve bone mineral density, back pain and reduce the risk of new fractures due to osteoporosis. The outcomes will be evaluated by bone densitometry at the lumbar spine and femoral neck, by standard radiographs, by measurements of bone formation marker (P1NP) and by questionnaires on back pain and quality of life. Postmenopausal women and men over 21 years old may be included if they have:
1. at least 3 severe vertebral fractures
2. 2 severe vertebral fractures and 1 hip fracture
3. an incidental vertebral fracture or an hip fracture during treatment with antiresorptives prescribed for at least 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 794
- Postmenopausal women and men older than 21 years affected by severe osteoporosis with an incidental vertebral or hip fracture during treatment with an antiresorptive, or having 3 or more severe vertebral fractures or having 2 severe vertebral fractures and an historical hip fracture.
- Any contraindication for the use of antiosteoporotic drug
- Premenopausal women or men younger than 21 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with severe osteoporosis Teriparatide Postmenopausal women and men aged \> 21 years old affected by severe osteoporosis
- Primary Outcome Measures
Name Time Method Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication. From 0 to 24 months
- Secondary Outcome Measures
Name Time Method Treatment compliance From 0 to 24 months Reason of discontinuation From 0 to 24 months BMD changes (lumbar and femoral BMD) From 0 to 24 months Changes in bone turnover marker measured by P1NP From 0 to 24 months Quality of Life (measured by EQ-5D of EuroQol Group) From 0 to 24 months Back Pain measured by visual analogue scale and back pain questionnaire From 0 to 24 months Assessment of motor performance and chair rising test From 0 to 24 months
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this study, 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.
🇮🇹Valeggio sul Mincio, Verona, Italy