Session: SAT 224-247-Osteoporosis I
Poster Board SAT-231
Patients: Eighty women 50-70 years with osteoporosis and ongoing estrogen hormone replacement (HRT) were studied and compared with an age-matched random population sample of women (n=120), the WHO MONICA project, Gothenburg.
Methods: A double blind, placebo controlled study was performed. Patients were randomized to GH 1.0 Unit (U) or GH 2.5U (Genotropin®) daily during 3 years or corresponding volumes of placebo subcutaneously. All received calcium 750 mg and vitamin D 400 units and followed-up during 10 years. Bone mineral density (BMD) and content (BMC) were measured with DXA annually until 6 years and then every second year. QoL was estimated with the Short Form (SF-36) annually. The patients were examined annually while the controls were examined at start and after 10 years by the same staff. The same methods were used on all occasions.
Results: GH increased BMD and BMC dose dependently in all regions (p=0.01 GH 1.0 U and p=0.0006 GH 2.5U vs placebo) until 5 years. Thereafter BMD and BMC declined in both GH groups and did not differ from the placebo group. At 10 years, all groups had BMD and BMC similar to baseline. After 10 years, the amount of patients who fractured decreased from 56% to 28% (p=0.0003), evenly distributed between groups. Serum IGF-1 was lower in patients who fractured during follow-up (p=0.01). No one dropped out. Six of the oldest patients died (2 high dose GH, 1 low dose GH and 3 placebo). HRT use decreased from 100% to 41% while 23% had started with bisphosphonates and 3% had received teriparatide among patients. In controls, the women who fractured increased from 8% to 32% (p=0.0008), HRT use decreased from 40% to 8% while use of bone specific agents increased from 0 to 4% only. QoL did not change during GH-treatment or during the 10-year follow-up in the patients and did not differ compared with controls.
Conclusion: GH-treatment was beneficial for the bone mass and fracture outcome after 10 years but did not affect QoL in postmenopausal women with osteoporosis. The QoL was similar to women in the general population. The fracture incidence decreased in treated women with osteoporosis and increased in the population, where bone specific agents were rarely used, at follow-up.
Nothing to Disclose: KL, EA, PT
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