Vitamin D3 analogs for the treatment of osteoporosis

2015 ◽  
Vol 93 (5) ◽  
pp. 327-332 ◽  
Author(s):  
Hiroshi Hagino
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Bone Turnover ◽  
Bone Turnover Markers ◽  
Mineral Density ◽  
Double Blind ◽  
Treatment Of Osteoporosis ◽  
Dihydroxyvitamin D ◽  
Ovx Rats ◽  
Turnover Markers

Vitamin D supplementation is recommended whenever patients are given therapeutic drugs for osteoporosis, to make their calcium (Ca) balance positive. Vitamin D is converted to 25-hydroxyvitamin D in the liver, and then activated to become 1α,25-dihydroxyvitamin D in the kidneys. The active vitamin D acts in the intestine to stimulate Ca absorption and maintain the Ca balance. 2β-(3-Hydroxypropyloxy)-1α,25-dihydroxyvitamin D3 (eldecalcitol) and 2-methylene-19-nor-(20S)-1α,25-dihydroxyvitamin D3 (2MD) are newly developed vitamin D analogs, with a substitution at the 2 position of 1α,25-dihydroxyvitamin D3 (calcitriol). Eldecalcitol and 2MD share common structural and biological characteristics. Both compounds increase serum Ca levels more markedly than calcitriol, increase bone mineral density (BMD), and improve bone strength in ovariectomized (OVX) rats. In a randomized, placebo-controlled, double-blind, 1 year clinical trial, eldecalcitol dose-dependently increased lumbar and hip BMD and suppressed bone turnover markers in patients with osteoporosis. Whereas, 2MD markedly increased the bone turnover markers, but it did not change the BMD of postmenopausal women with osteopenia in a 1 year clinical trial. After a randomized, double-blind, 3 year fracture-prevention trial comparing it with alfacalcidol, eldecalcitol was approved for the treatment of osteoporosis in Japan. On the other hand, the manufacturer discontinued the clinical development of 2MD. In this review, we discuss the similarities and differences between these 2 compounds, and the reasons why different outcomes resulted from their clinical trials.

scholarly journals The effect of short-term low-energy ultraviolet B irradiation on bone mineral density and bone turnover markers in postmenopausal women with osteoporosis: A randomized single-blinded controlled clinical trial

2013 ◽  
Vol 141 (9-10) ◽  
pp. 615-622 ◽  
Author(s):  
Ivan Micic ◽  
In-Ho Jeon ◽  
So-Hyun Park ◽  
Seo-Sung Hwa ◽  
Jae-Myeung Chun ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Bone Turnover ◽  
Postmenopausal Women ◽  
Bone Turnover Markers ◽  
Low Energy ◽  
Controlled Clinical Trial ◽  
Mineral Density ◽  
Short Term ◽  
Turnover Markers

Introduction. The importance of vitamin D on bone health and osteoporosis was studied by many researchers. The main role of the Vitamin D is to absorb calcium and phosphate and increase bone mineralization. Older people are at an increased risk of the inadequate vitamin D production in the skin because of lower sun exposure and reduced ability of the skin to synthesize vitamin D. Objective. The aim of this clinical trial was to evaluate the efficacy and tolerability of short-term (2 weeks) low energy UVB irradiation in postmenopausal women with osteoporosis using bone mineral density and bone turnover markers. Methods. A three-month, single-blinded, randomized, placebo-controlled clinical trial was conducted at the University hospital in Daegu, Republic of Korea. Fifty-two postmenopausal Korean women (older than 65 years) with osteoporosis were randomly allocated to have either low energy UVB or placebo for 30 minutes a day for two weeks of treatment during winter. Laboratory analysis and physical examination before and 4, 8 and 12 weeks after treatment were carried out and BMD was measured before and 8 and 12 weeks after treatment. The effects of time and treatment interaction between these two groups were evaluated by repeated-measure two-factor analysis, and subgroup analysis was performed to examine UVB effect on the vitamin D insufficient group [serum 25(OH)D3 concentration <30 ng/mL]. Results. In vitamin D insufficient group, the effect of UVB irradiation on vitamin D and bone ALP as well as additional benefit on bone formation was confirmed. The vitamin D insufficient group showed statistically significant increment in serum 25(OH)D3 compared with the normal group (p<0.05). However, there was no significant difference between two groups in the other bone turnover markers, such as serum calcium, PTH-C, serum osteocalcin, serum CTX and BMD. Conclusion. Low-energy-short-term UVB radiation for postmenopausal women may be of use in vitamin D synthesis. There was a modest benefit in change of bone ALP especially in women with the insufficient vitamin D.

Denosumab in Osteoporosis and Oncology

2009 ◽  
Vol 43 (9) ◽  
pp. 1445-1455 ◽  
Author(s):  
Jill S Burkiewicz ◽  
Sarah L Scarpace ◽  
Susan P Bruce
Keyword(s):  
Breast Cancer ◽  
Prostate Cancer ◽  
Adverse Effects ◽  
Bone Turnover ◽  
Bone Turnover Markers ◽  
Neoplastic Disease ◽  
Mineral Density ◽  
Treatment Of Osteoporosis ◽  
Additional Clinical Trial ◽  
Turnover Markers

Objective: To review the pharmacology, pharmacokinetics, pharmacodynamics, safety, efficacy, and use of denosumab in osteoporosis, breast cancer, prostate cancer, and multiple myeloma. Data Sources: Studies and abstracts were identified through MEDLINE and International Pharmaceutical Abstracts (1966–July 2009). Key search terms include denosumab, AMG-162, and receptor activator of nuclear factor-κB ligand system. Information available in abstract form was retrieved from major oncology and bone metabolism meetings. Additional data were obtained from the manufacturer. Study Selection and Data Extraction: All available studies in humans were included except for studies in rheumatoid arthritis and giant cell tumor of the bone. Data Synthesis: In patients with osteoporosis, denosumab significantly reduces bone resorption and fractures. Studies of denosumab in the prevention and treatment of osteoporosis have demonstrated significantly increased bone mineral density and reduced bone turnover markers. Studies of denosumab versus placebo in the treatment of osteoporosis have demonstrated reductions in vertebral, hip, and nonvertebral fractures. In oncology, positive results from clinical trials in patients receiving endocrine therapy for breast and prostate cancer demonstrated decreases in bone loss and skeletal-related events. Denosumab seems to be at least as effective in reducing bone turnover markers as intravenous bisphosphonates in the oncology setting. The most common adverse effects in patients with osteoporosis were arthralgia, nasopharyngitis, back pain, and headache. The most common adverse effects in patients with cancer were infection, pain in the extremities, arthralgia, bone pain, fatigue, and pain. Serious adverse effects include infections requiring hospitalization. Conclusions: Denosumab has documented efficacy and safety in patients with osteoporosis, breast cancer, and prostate cancer. Additional clinical trial data are needed to more completely establish the effectiveness of denosumab in the treatment of osteoporosis and neoplastic disease as well as its cost-effectiveness and long-term safety.

25-hydroxy vitamin D levels in healthy premenopausal women: Association with bone turnover markers and bone mineral density

Bone ◽  
2009 ◽  
Vol 45 (3) ◽  
pp. 423-426 ◽  
Author(s):  
Silvano Adami ◽  
Francesco Bertoldo ◽  
Vania Braga ◽  
Elena Fracassi ◽  
Davide Gatti ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Vitamin D ◽  
Bone Turnover ◽  
Bone Mineral ◽  
Bone Turnover Markers ◽  
Premenopausal Women ◽  
Mineral Density ◽  
Vitamin D Levels ◽  
25 Hydroxy Vitamin D ◽  
Turnover Markers
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