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Wednesday, July 10, 2013

Hormone Effective for Steroid-Induced Osteoporosis

The synthetic parathyroid hormone teriparatide is an effective treatment for glucocorticoid-induced osteoporosis, a form of bone loss seen in patients treated with steroids, according to a study funded by the manufacturer.

Patients with glucocorticoid-induced osteoporosis who took teriparatide for 36 months had greater increases in bone mineral density and fewer vertebral fractures than those treated with alendronate, a bisphosphonate osteoporosis drug sold as Fosamax, an online article in Arthritis & Rheumatism reported.

Subjects at high risk of fracture associated with sustained glucocorticoid use who received teriparatide had significantly greater increases in spine and hip BMD compared with subjects receiving alendronate during the 36 months of therapy.

Patients with glucocorticoid-induced osteoporosis treated with teriparatide also experienced significantly fewer new vertebral fractures, most occurring during the first 18 months, with no significant difference between groups in the incidence of nonvertebral fractures."

Glucocorticoids are used to control inflammation in patients with autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, and Crohn's disease, as well as inflammatory conditions such as asthma.

However, long-term use of glucocorticoids such as prednisone, prednisolone, dexamethasone, and cortisone can result in reduced bone mass and strength, increasing fracture risk.

In the new study, participants were randomly assigned to receive injectable teriparatide (20 µg/day) plus oral placebo (150 subjects) or oral alendronate (10 mg/day) plus injectable placebo (144 subjects). They were also given supplements of calcium and vitamin D.

In addition to seeing greater improvements in bone mineral density and fewer vertebral fractures, subjects who took teriparatide saw significant increases in levels of biomarkers of bone turnover, including N-terminal type I procollagen propeptide (PINP), osteocalcin (OC) and C-terminal telopeptide of type I collagen (CTX).

More patients who took teriparatide (21%) had elevated predose serum calcium concentrations compared with those in the alendronate group (7%)"Our data indicated that teriparatide is efficacious and generally well tolerated for treating subjects with glucocorticoid-induced [osteoporosis] and should be considered as a therapeutic option for subjects at high risk of fracture," the authors concluded.

They noted that the study had a high dropout rate, with 44% of patients leaving during the three years, which might have reflected the severity of the disorders being treated and the propensity for the patients to have other diseases. However, there was no difference in dropout rates between the two study groups.

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