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Bone Remodeling Begins Soon After Starting Teriparatide Therapy: Presented at ENDO

By Mike Fillon

NEW ORLEANS, LA -- June 18, 2004 -- A subanalysis of the Fracture Prevention Trial, (FPT) shows that changes in bone remodeling markers occur in women with osteoporosis after 1 month of treatment with Teriparatide (teriparatide [rDNA origin] injection.)

Results of the study were reported here June 16th in a poster presentation at the 86th Annual Meeting of The Endocrine Society.

The FPT was a randomized, double-blinded, placebo controlled study that enrolled 1,637 women with osteoporosis and randomized them to teriparatide at 20 mcg/day, 40 mcg/day or placebo for a median of 19 months.

The subanalysis of 527 patients found that as early as 1 month into treatment, changes in markers of bone remodeling, particularly serum carboxy-terminal propeptide of type I collagen (PICP), provided important predictive information of subsequent bone mineral density (BMD) increases in response to teriparatide. BMD is used to both diagnose osteoporosis and monitor treatment effectiveness. Unlike BMD measurements, markers of bone remodeling are able to detect delicate changes in the bone early in the treatment cycle -- sometimes within weeks of beginning treatment.

"These findings are significant because they provide physicians and patients early evidence that treatment with teriparatide is working," said lead investigator Dr. Angelo Licata, endocrinologist, Cleveland Clinic, Ohio. "Providing physicians and patients with this information early in their treatment is crucial in that it may help promote compliance, a common roadblock in osteoporosis treatment."

The objective of this subanalysis was to determine if changes in markers of bone turnover could predict increases in BMD at the lumbar spine after 18 months of treatment. The researchers assessed 2 markers of bone formation (serum bone-specific alkaline phosphatase [BSAP], PICP) and two markers of bone resorption (urinary free deoxypyridinoline/creatinine ratio [DPD], urinary N-terminal telopeptide/creatinine ratio [NTx]) and lumbar spine BMD.

As was observed in the FPT, markers of formation, PICP and BSAP, increased after 1 month of treatment. Levels of PICP for teriparatide 20 mcg and 40 mcg declined after 1 month and returned to near baseline levels by 12 months. Markers of resorption -- NTx and DPD -- increased after 1 month of treatment. All of theses changes were statistically significant from baseline and placebo.

Teriparatide was approved by the Food and Drug Administration on Nov. 26, 2002 for treatment of osteoporosis in postmenopausal women who are at high risk for fracture and to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. These include men (and postmenopausal women) with a history of osteoporosis-related fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy, based on physician assessment. It stimulates new bone formation by increasing the number and activity of bone forming cells called osteoblasts.

This study was supported by Eli Lilly and Company.


[Presentation title: "Correlations between Early Changes in Bone Turnover Markers and Bone Mineral Density Response to Teriparatide in Postmenopausal Women with Osteoporosis." Abstract #OR11-3]

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