Safety and efficacy of teriparatide in elderly women with established osteoporosis: bone anabolic therapy from a geriatric perspective.

• OBJECTIVES: To assess the safety and efficacy of teriparatide in patients aged 75 and older and compare these findings with those of women younger than 75 using data from the Fracture Prevention Trial (FPT). DESIGN: The FPT was a randomized, multicenter, double-blind, placebo-controlled study. SETTING: The FPT multicenter international study. PARTICIPANTS: Postmenopausal women aged 42 to 86 were randomized to placebo (N=544) or teriparatide 20 mug (N=541) by daily self-injection for a median of 19 months. Patients received daily oral supplements of 1,000 mg calcium and 400 to 1,200 IU vitamin D. For this analysis, subgroups were defined according to patient age younger than 75 (N=841) and 75 and older (N=244). MEASUREMENTS: The effects of teriparatide on bone mineral density (BMD) of the lumbar spine and femoral neck; the incidence of new vertebral and new nonvertebral fragility fractures; bone turnover markers, including bone-specific alkaline phosphatase; and urinary deoxypyridinoline corrected for creatinine clearance, as well as the safety of teriparatide, were investigated. RESULTS: There were no significant treatment-by-age interactions for the bone turnover markers, femoral neck BMD, vertebral fractures, nonvertebral fragility fractures, height loss, hyperuricemia, or hypercalcemia. A significant treatment-by-age interaction for lumbar spine BMD (P=.08) was due to an increase in BMD observed in the placebo group aged 75 and older. There were no treatment-by-age interactions for important treatment-emergent adverse events (TEAEs), including back pain, nausea, leg cramps, and dizziness. The most important TEAEs in women aged 80 and older (23 patients from the placebo group and 25 patients from the teriparatide group) were also reviewed; no unexpected TEAEs were found in the patients treated with teriparatide. These results indicate that the clinical effects of teriparatide were consistent in the older and younger women. CONCLUSION: Age does not affect the safety and efficacy of teriparatide in postmenopausal women with osteoporosis.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)

Nyckelord

Age Factors

Aged

Aged

80 and over

Bone Density

drug effects

Bone Density Conservation Agents

pharmacology

therapeutic use

Bone Remodeling

drug effects

Double-Blind Method

Female

Femur Neck

physiopathology

Fractures

Bone

etiology

prevention & control

Humans

Hypercalcemia

epidemiology

Hyperuricemia

epidemiology

Incidence

Lumbar Vertebrae

injuries

physiopathology

Osteoporosis

Postmenopausal

complications

drug therapy

physiopathology

Teriparatide

pharmacology

therapeutic use

Treatment Outcome

Publikations- och innehållstyp

ref (ämneskategori)

art (ämneskategori)