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Randomized, double-blinded, placebo-controlled, trial of risedronate for the prevention of bone mineral density loss in nonmetastatic prostate cancer patients receiving radiation therapy plus androgen deprivation therapy.
Int J Radiat Oncol Biol Phys 2013; 85(5):1239-45IJ

Abstract

PURPOSE

Androgen deprivation therapy (ADT) has been used as an adjuvant treatment to radiation therapy (RT) for the management of locally advanced prostate carcinoma. Long-term ADT decreases bone mineral density (BMD) and increases the risk of osteoporosis. The objective of this clinical trial was to evaluate the efficacy of risedronate for the prevention of BMD loss in nonmetastatic prostate cancer patients undergoing RT plus 2 to 3 years of ADT.

METHODS AND MATERIALS

A double-blinded, placebo-controlled, randomized trial was conducted for nonmetastatic prostate cancer patients receiving RT plus 2 to 3 years of ADT. All had T scores > -2.5 on dual energy x-ray absorptiometry at baseline. Patients were randomized 1:1 between risedronate and placebo for 2 years. The primary endpoints were the percent changes in the BMD of the lumbar spine at 1 and 2 years from baseline, measured by dual energy x-ray absorptiometry. Analyses of the changes in BMD and bone turnover biomarkers were carried out by comparing mean values of the intrapatient changes between the 2 arms, using standard t tests.

RESULTS

One hundred four patients were accrued between 2004 and 2007, with 52 in each arm. Mean age was 66.8 and 67.5 years for the placebo and risedronate, respectively. At 1 and 2 years, mean (±SE) BMD of the lumbar spine decreased by 5.77% ± 4.66% and 13.55% ± 6.33%, respectively, in the placebo, compared with 0.12% ± 1.29% at 1 year (P=.2485) and 0.85% ± 1.56% (P=.0583) at 2 years in the risedronate. The placebo had a significant increase in serum bone turnover biomarkers compared with the risedronate.

CONCLUSIONS

Weekly oral risedronate prevented BMD loss at 2 years and resulted in significant suppression of bone turnover biomarkers for 24 months for patients receiving RT plus 2 to 3 years of ADT.

Authors+Show Affiliations

Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23265571

Citation

Choo, Richard, et al. "Randomized, Double-blinded, Placebo-controlled, Trial of Risedronate for the Prevention of Bone Mineral Density Loss in Nonmetastatic Prostate Cancer Patients Receiving Radiation Therapy Plus Androgen Deprivation Therapy." International Journal of Radiation Oncology, Biology, Physics, vol. 85, no. 5, 2013, pp. 1239-45.
Choo R, Lukka H, Cheung P, et al. Randomized, double-blinded, placebo-controlled, trial of risedronate for the prevention of bone mineral density loss in nonmetastatic prostate cancer patients receiving radiation therapy plus androgen deprivation therapy. Int J Radiat Oncol Biol Phys. 2013;85(5):1239-45.
Choo, R., Lukka, H., Cheung, P., Corbett, T., Briones-Urbina, R., Vieth, R., ... Danjoux, C. (2013). Randomized, double-blinded, placebo-controlled, trial of risedronate for the prevention of bone mineral density loss in nonmetastatic prostate cancer patients receiving radiation therapy plus androgen deprivation therapy. International Journal of Radiation Oncology, Biology, Physics, 85(5), pp. 1239-45. doi:10.1016/j.ijrobp.2012.11.007.
Choo R, et al. Randomized, Double-blinded, Placebo-controlled, Trial of Risedronate for the Prevention of Bone Mineral Density Loss in Nonmetastatic Prostate Cancer Patients Receiving Radiation Therapy Plus Androgen Deprivation Therapy. Int J Radiat Oncol Biol Phys. 2013 Apr 1;85(5):1239-45. PubMed PMID: 23265571.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, double-blinded, placebo-controlled, trial of risedronate for the prevention of bone mineral density loss in nonmetastatic prostate cancer patients receiving radiation therapy plus androgen deprivation therapy. AU - Choo,Richard, AU - Lukka,Himu, AU - Cheung,Patrick, AU - Corbett,Tom, AU - Briones-Urbina,Rosario, AU - Vieth,Reinhold, AU - Ehrlich,Lisa, AU - Kiss,Alex, AU - Danjoux,Cyril, Y1 - 2012/12/19/ PY - 2012/09/26/received PY - 2012/10/29/revised PY - 2012/11/02/accepted PY - 2012/12/26/entrez PY - 2012/12/26/pubmed PY - 2013/5/10/medline SP - 1239 EP - 45 JF - International journal of radiation oncology, biology, physics JO - Int. J. Radiat. Oncol. Biol. Phys. VL - 85 IS - 5 N2 - PURPOSE: Androgen deprivation therapy (ADT) has been used as an adjuvant treatment to radiation therapy (RT) for the management of locally advanced prostate carcinoma. Long-term ADT decreases bone mineral density (BMD) and increases the risk of osteoporosis. The objective of this clinical trial was to evaluate the efficacy of risedronate for the prevention of BMD loss in nonmetastatic prostate cancer patients undergoing RT plus 2 to 3 years of ADT. METHODS AND MATERIALS: A double-blinded, placebo-controlled, randomized trial was conducted for nonmetastatic prostate cancer patients receiving RT plus 2 to 3 years of ADT. All had T scores > -2.5 on dual energy x-ray absorptiometry at baseline. Patients were randomized 1:1 between risedronate and placebo for 2 years. The primary endpoints were the percent changes in the BMD of the lumbar spine at 1 and 2 years from baseline, measured by dual energy x-ray absorptiometry. Analyses of the changes in BMD and bone turnover biomarkers were carried out by comparing mean values of the intrapatient changes between the 2 arms, using standard t tests. RESULTS: One hundred four patients were accrued between 2004 and 2007, with 52 in each arm. Mean age was 66.8 and 67.5 years for the placebo and risedronate, respectively. At 1 and 2 years, mean (±SE) BMD of the lumbar spine decreased by 5.77% ± 4.66% and 13.55% ± 6.33%, respectively, in the placebo, compared with 0.12% ± 1.29% at 1 year (P=.2485) and 0.85% ± 1.56% (P=.0583) at 2 years in the risedronate. The placebo had a significant increase in serum bone turnover biomarkers compared with the risedronate. CONCLUSIONS: Weekly oral risedronate prevented BMD loss at 2 years and resulted in significant suppression of bone turnover biomarkers for 24 months for patients receiving RT plus 2 to 3 years of ADT. SN - 1879-355X UR - https://www.unboundmedicine.com/medline/citation/23265571/Randomized_double_blinded_placebo_controlled_trial_of_risedronate_for_the_prevention_of_bone_mineral_density_loss_in_nonmetastatic_prostate_cancer_patients_receiving_radiation_therapy_plus_androgen_deprivation_therapy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0360-3016(12)03750-9 DB - PRIME DP - Unbound Medicine ER -