Introduction: Teriparatide (TPTD) is a recombinant aminoterminal fragment (134) of the human parathyroid hormone (PTH), which has a predominantly stimulating effect on bone formation. We report results of an 18-month prospective multicenter study with daily s.c. application of 20 μg of teriparatide in 85 elderly women with severe osteoporosis, the efficacy, safety and compliance of the treatment.
Outcomes: The primary outcomes were defined as changes from basal/basic BMD of femoral neck, total hip and lumbar spine after 12 and 18 months. Another primary outcome was defined as an analysis of serum level changes of bone turnover markers after 6 and 18 months. Secondary outcomes included prevalence of clinical fractures, tolerability and safety of the treatment.
Design and participants: The prospective, open label, non-randomized, single-armed 18-month study in five centers in the Slovak republic. The inclusion criteria were: 1) bone mass density (BMD) T score < −2.9 in the region of the femoral neck, or hip and two or more vertebral fractures and 2) the failure of previous antiresorptive treatment. All patients were daily applicated subcutaneously 20 μg of recombinant humane parathyroide hormone (134) teriparatide (Forsteo, Eli Lilly and Company, Nederland BV). All enrolled women received daily supplements of 5001000 mg of calcium and 400800 IU of Vitamin D.
Methods: The bone mineral density of lumbar spine (L14), femoral neck and total hip was measured before treatment (base line) and at 12 and 18 months usingdual-energy X-ray (DXA Hologic). We measured the concentration of C-telopeptide of collagen CTx) and osteocalcin (OC) at base line and at 6 and 18 months. Statistical analyses were performed according to the intention-to-treat principle. T-test was used to determine the changes in percentage of BMD and levels of serum markers in 6, 12 and 18 months compared to baseline.
Results: Treatment with TPTD resulted in increase of bone mineral density of the total hip during 12 months (+3.5%, P=0.066) and significant increase of BMD in 18 months of treatment (+3.7%, P=0.026). The BMD changes in the femoral neck region were also significant, we observed an increase of BMD +4.6% (P=0.041) in 18 months. The most significant increase of BMD was found in the lumbar spine region, +9.2% (P=0.002) during 12 months of treatment and an increase of 10.6% after 18 months of treatment with TPT (P=0.001). Over 18 months of teriparatide therapy led to significant increase of CTx and osteocalcin. The increase of CTx was 173% after 6 months and 93% after 18 months (P<0.001). As for osteocalcin, the increase of serum level represented 134% after 6 and also 18 months of therapy (P<0.001). Treatment was well tolerated and no serious side effects were observed. Borderline hypercalcemia was present in 5.3% of patients, but it has no clinical relevance.
Conclusion: Osteoanabolic treatment using teriparatide was effective, well tolerated and safe. According to or results parathormone could be a drug of choice in postmenopausal women with severe osteoporosis.
Prague, Czech Republic
24 - 28 Apr 2010
European Society of Endocrinology