Emily Krantz1, Penelope Trimpou1, Kerstin Landin-Wilhelmsen1. 1. Clinic for Internal Medicine (E.K.), Södra Älvsborgs Hospital, SE-501 82 Borås, Sweden; and Section for Endocrinology (P.T., K.L.-W.), Sahlgrenska University Hospital at Sahlgrenska Academy, University of Gothenburg, SE-413 45 Gothenburg, Sweden.
Abstract
CONTEXT: Growth hormone (GH) treatment increases bone mineral density (BMD) in women with postmenopausal osteoporosis. OBJECTIVE: The objective was to report bone data, fractures, and quality of life (QoL) in a 10-year follow-up of women who had received GH for 3 years and compared with controls followed in parallel. DESIGN AND SETTING: A follow-up of a double-blind, placebo-controlled study conducted at Sahlgrenska University Hospital was performed. PATIENTS: Eighty women aged between 50 and 70 years with osteoporosis and estrogen hormone replacement were studied and compared with an age-matched random population sample of women (n = 120) from the World Health Organization Monitoring of Trends and Determinants in Cardiovascular Disease project (Gothenburg, Sweden). INTERVENTIONS: Patients were randomized to GH 1.0 U or GH 2.5U recombinant human GH or placebo sc daily during 3 years. All received calcium 750 mg and vitamin D 400 U and were followed up during 10 years. MAIN OUTCOME MEASURES: BMD and bone mineral content were measured with dual-energy X-ray absorptiometry. QoL was estimated with the 36-item Short Form. RESULTS:GH increased BMD and bone mineral content dose dependently in all regions (P = .01, GH 1.0 U, and P = .0006, GH 2.5 U vs placebo). After 10 years the number of fractures decreased from 56% to 28% (P = .0003) in patients evenly distributed between groups. In controls, fractures increased from 8% to 32% (P = .0008). QoL did not change during GH treatment or during the 10-year follow-up and did not differ compared with controls. CONCLUSION:GH treatment was beneficial for bone and fracture outcome after 10 years but did not affect the QoL of the women with postmenopausal osteoporosis.
RCT Entities:
CONTEXT: Growth hormone (GH) treatment increases bone mineral density (BMD) in women with postmenopausal osteoporosis. OBJECTIVE: The objective was to report bone data, fractures, and quality of life (QoL) in a 10-year follow-up of women who had received GH for 3 years and compared with controls followed in parallel. DESIGN AND SETTING: A follow-up of a double-blind, placebo-controlled study conducted at Sahlgrenska University Hospital was performed. PATIENTS: Eighty women aged between 50 and 70 years with osteoporosis and estrogen hormone replacement were studied and compared with an age-matched random population sample of women (n = 120) from the World Health Organization Monitoring of Trends and Determinants in Cardiovascular Disease project (Gothenburg, Sweden). INTERVENTIONS:Patients were randomized to GH 1.0 U or GH 2.5 U recombinant human GH or placebo sc daily during 3 years. All received calcium 750 mg and vitamin D 400 U and were followed up during 10 years. MAIN OUTCOME MEASURES: BMD and bone mineral content were measured with dual-energy X-ray absorptiometry. QoL was estimated with the 36-item Short Form. RESULTS: GH increased BMD and bone mineral content dose dependently in all regions (P = .01, GH 1.0 U, and P = .0006, GH 2.5 U vs placebo). After 10 years the number of fractures decreased from 56% to 28% (P = .0003) in patients evenly distributed between groups. In controls, fractures increased from 8% to 32% (P = .0008). QoL did not change during GH treatment or during the 10-year follow-up and did not differ compared with controls. CONCLUSION: GH treatment was beneficial for bone and fracture outcome after 10 years but did not affect the QoL of the women with postmenopausal osteoporosis.
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