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Combination Teriparatide and Raloxifene Therapy for Postmenopausal Osteoporosis: Results From a 6‐Month Double‐Blind Placebo‐Controlled Trial
Author(s) -
Deal Chad,
Omizo Molly,
Schwartz Elliott N,
Eriksen Erik F,
Cantor Per,
Wang Jingyuan,
Glass Emmett V,
Myers Stephen L,
Krege John H
Publication year - 2005
Publication title -
journal of bone and mineral research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.882
H-Index - 241
eISSN - 1523-4681
pISSN - 0884-0431
DOI - 10.1359/jbmr.050714
Subject(s) - teriparatide , medicine , raloxifene , osteoporosis , n terminal telopeptide , placebo , femoral neck , urology , endocrinology , bone resorption , bone remodeling , bone mineral , combination therapy , bone density , breast cancer , chemistry , osteocalcin , estrogen receptor , pathology , biochemistry , alkaline phosphatase , alternative medicine , cancer , enzyme
We compared combination treatment with teriparatide plus raloxifene with teriparatide alone in women with postmenopausal osteoporosis in a 6‐month double‐blind, placebo‐controlled trial that measured biochemical markers of bone turnover and BMD. Markers of bone formation and spine BMD increased similarly with teriparatide alone and combination therapy. However, combination therapy induced a significantly smaller increase in bone resorption versus teriparatide alone and significantly increased total hip BMD versus baseline. Introduction : The effects of combining two approved treatments for osteoporosis with different modes of action were examined by comparing teriparatide [rhPTH(1–34)] monotherapy with combination teriparatide and raloxifene therapy. Materials and Methods : A 6‐month randomized, double‐blind trial comparing teriparatide plus raloxifene ( n = 69) versus teriparatide plus placebo ( n = 68) was conducted in postmenopausal women with osteoporosis. Results : Bone formation (N‐terminal propeptide of type 1 collagen [PINP]) increased similarly in both treatment groups. However, the increase in bone resorption (serum C‐terminal telopeptide of type I collagen [CTx]) in the combination group was significantly smaller than in the teriparatide‐alone group ( p = 0.015). Lumbar spine BMD significantly increased 5.19 ± 0.67% from baseline in the teriparatide‐alone group. In the combination group, lumbar spine (6.19 ± 0.65%), femoral neck (2.23 ± 0.64%), and total hip (2.31 ± 0.56%) BMD significantly increased from baseline to study endpoint, and the increase in total hip BMD was significantly greater than in the teriparatide‐alone group ( p = 0.04). In the teriparatide‐alone group, mean serum calcium levels increased from baseline to endpoint (0.30 ± 0.06 mg/dl, p < 0.001), whereas mean serum phosphate remained unchanged. In the combination group, mean serum calcium was unchanged, and mean serum phosphate decreased (−0.20 ± 0.06 mg/dl, p < 0.001) from baseline to endpoint. Changes in serum calcium ( p < 0.001) and phosphate ( p < 0.004) were significantly different between treatment groups. The safety profile of combination therapy was similar to teriparatide alone. Conclusions : Combination therapy increased bone formation to a similar degree as teriparatide alone. However, the increase in bone resorption was significantly less and total hip BMD significantly increased for combination therapy compared with teriparatide alone. Combination treatment with raloxifene may thus enhance the bone forming effects of teriparatide. Further studies over longer treatment duration that include fracture endpoints are necessary to fully ascertain the clinical significance of combination raloxifene plus teriparatide therapy in postmenopausal osteoporosis.