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


METHODS
The FPT was a randomized, multicenter, double-blind, placebo-controlled study.


METHODS
The FPT multicenter international study.


METHODS
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).


METHODS
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.


CONCLUSIONS
Age does not affect the safety and efficacy of teriparatide in postmenopausal women with osteoporosis.
Boonen
Steven
S
Leuven University Center for Metabolic Bone Diseases and Division of Geriatric Medicine, Katholieke Universiteit Leuven, Herestraat 49, B-3000 Leuven, Belgium. steven.boonen@uz.kuleuven.ac.be
Marin
Fernando
F
Mellstrom
Dan
D
Xie
Li
L
Desaiah
Durisala
D
Krege
John H
JH
Rosen
Clifford J
CJ
D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000494:pharmacology* / Q000627:therapeutic use; D016723:Bone Remodeling / Q000187:drug effects*; D004311:Double-Blind Method; D005260:Female; D005272:Femur Neck / Q000503:physiopathology; D050723:Fractures, Bone / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D006934:Hypercalcemia / Q000453:epidemiology; D033461:Hyperuricemia / Q000453:epidemiology; D015994:Incidence; D008159:Lumbar Vertebrae / Q000293:injuries / Q000503:physiopathology; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy / Q000503:physiopathology*; D019379:Teriparatide / Q000494:pharmacology* / Q000627:therapeutic use; D016896:Treatment Outcome
D050071:Bone Density Conservation Agents; D019379:Teriparatide