A Study for Teriparatide in Severe Osteoporosis (ISSO)

• Treatment compliance [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]
• Reason of discontinuation [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]
• BMD changes (lumbar and femoral BMD) [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]
• Changes in bone turnover marker measured by P1NP [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]
• Quality of Life (measured by EQ-5D of EuroQol Group) [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]
• Back Pain measured by visual analogue scale and back pain questionnaire [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]
• Assessment of motor performance and chair rising test [ Time Frame: From 0 to 24 months ] [ Designated as safety issue: No ]

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.

Primary care clinic

• Osteoporosis, Postmenopausal
• Osteoporosis

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