A Study for Teriparatide in Severe Osteoporosis (ISSO)
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About
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.
Full 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:
- at least 3 severe vertebral fractures
- 2 severe vertebral fractures and 1 hip fracture
- an incidental vertebral fracture or an hip fracture during treatment with antiresorptives prescribed for at least 12 months.
Enrollment
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Inclusion criteria
- 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.
Exclusion criteria
- Any contraindication for the use of antiosteoporotic drug
- Premenopausal women or men younger than 21 years
Trial design
794 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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