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.
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.
Study Type
OBSERVATIONAL
Enrollment
794
20 mcg daily subcutaneous for 18 months.
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
Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication.
Time frame: From 0 to 24 months
Treatment compliance
Time frame: From 0 to 24 months
Reason of discontinuation
Time frame: From 0 to 24 months
BMD changes (lumbar and femoral BMD)
Time frame: From 0 to 24 months
Changes in bone turnover marker measured by P1NP
Time frame: From 0 to 24 months
Quality of Life (measured by EQ-5D of EuroQol Group)
Time frame: From 0 to 24 months
Back Pain measured by visual analogue scale and back pain questionnaire
Time frame: From 0 to 24 months
Assessment of motor performance and chair rising test
Time frame: From 0 to 24 months
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