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Randomized trial of once-weekly parathyroid hormone (1-84) on bone mineral density and remodeling.
J Clin Endocrinol Metab. 2008 Jun; 93(6):2166-72.JC

Abstract

CONTEXT

Daily PTH administration increases bone mineral density (BMD) and reduces fracture risk. However, cost and compliance significantly limit clinical use.

OBJECTIVE

Our objective was to determine whether less frequent PTH administration increases lumbar spine BMD.

PARTICIPANTS, DESIGN, AND SETTING

Fifty postmenopausal women ages 45-70 yr with femoral neck BMD T-score between -1.0 and -2.0 participated in a double-blind, randomized, placebo-controlled trial at St. Joseph Hospital, Bangor, ME.

INTERVENTION

Subjects received sc injections of daily PTH(1-84) (100 mug) or placebo for 1 month, followed by weekly injections (PTH or placebo) for 11 months.

OUTCOMES

Change in lumbar spine dual-energy x-ray absorptiometry areal BMD (primary) was assessed. Secondary outcomes included volumetric BMD at spine and hip by quantitative computed tomography, trabecular bone microarchitecture by magnetic resonance imaging of distal radius, and biochemical bone turnover markers.

RESULTS

At 12 months, lumbar spine areal BMD increased 2.1% in PTH-treated women compared with placebo (P = 0.03). Vertebral trabecular volumetric BMD increased 3.8% in PTH-treated women compared with placebo group (P = 0.08). PTH-treated women also had higher distal radial trabecular bone volume, number, and thickness compared with placebo-treated women (P < 0.04). After 1 month of daily PTH, N-terminal propeptide of type I collagen (P1NP) was markedly increased compared with placebo (P < 0 .0001), and a difference persisted, although lessened, throughout the study. Bone resorption indices were unchanged in PTH-treated women and were reduced in the placebo group.

CONCLUSION

Once-weekly PTH after 1 month of daily treatment increases spine BMD, radial trabecular bone, and bone formation markers in postmenopausal women. These results suggest that less frequent alternatives to daily PTH dosing for 2 yr could be effective. Additional studies are required to define the optimal frequency of PTH administration.

Authors+Show Affiliations

Department of Epidemiology and Biostatistics, University of California-San Francisco, 185 Berry Street, San Francisco, CA 94107, USA. dblack@psg.ucsf.eduNo 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, N.I.H., Extramural

Language

eng

PubMed ID

18349061

Citation

Black, Dennis M., et al. "Randomized Trial of Once-weekly Parathyroid Hormone (1-84) On Bone Mineral Density and Remodeling." The Journal of Clinical Endocrinology and Metabolism, vol. 93, no. 6, 2008, pp. 2166-72.
Black DM, Bouxsein ML, Palermo L, et al. Randomized trial of once-weekly parathyroid hormone (1-84) on bone mineral density and remodeling. J Clin Endocrinol Metab. 2008;93(6):2166-72.
Black, D. M., Bouxsein, M. L., Palermo, L., McGowan, J. A., Newitt, D. C., Rosen, E., Majumdar, S., & Rosen, C. J. (2008). Randomized trial of once-weekly parathyroid hormone (1-84) on bone mineral density and remodeling. The Journal of Clinical Endocrinology and Metabolism, 93(6), 2166-72. https://doi.org/10.1210/jc.2007-2781
Black DM, et al. Randomized Trial of Once-weekly Parathyroid Hormone (1-84) On Bone Mineral Density and Remodeling. J Clin Endocrinol Metab. 2008;93(6):2166-72. PubMed PMID: 18349061.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized trial of once-weekly parathyroid hormone (1-84) on bone mineral density and remodeling. AU - Black,Dennis M, AU - Bouxsein,Mary L, AU - Palermo,Lisa, AU - McGowan,Joan A, AU - Newitt,David C, AU - Rosen,Eyal, AU - Majumdar,Sharmila, AU - Rosen,Clifford J, AU - ,, Y1 - 2008/03/18/ PY - 2008/3/20/pubmed PY - 2008/7/18/medline PY - 2008/3/20/entrez SP - 2166 EP - 72 JF - The Journal of clinical endocrinology and metabolism JO - J Clin Endocrinol Metab VL - 93 IS - 6 N2 - CONTEXT: Daily PTH administration increases bone mineral density (BMD) and reduces fracture risk. However, cost and compliance significantly limit clinical use. OBJECTIVE: Our objective was to determine whether less frequent PTH administration increases lumbar spine BMD. PARTICIPANTS, DESIGN, AND SETTING: Fifty postmenopausal women ages 45-70 yr with femoral neck BMD T-score between -1.0 and -2.0 participated in a double-blind, randomized, placebo-controlled trial at St. Joseph Hospital, Bangor, ME. INTERVENTION: Subjects received sc injections of daily PTH(1-84) (100 mug) or placebo for 1 month, followed by weekly injections (PTH or placebo) for 11 months. OUTCOMES: Change in lumbar spine dual-energy x-ray absorptiometry areal BMD (primary) was assessed. Secondary outcomes included volumetric BMD at spine and hip by quantitative computed tomography, trabecular bone microarchitecture by magnetic resonance imaging of distal radius, and biochemical bone turnover markers. RESULTS: At 12 months, lumbar spine areal BMD increased 2.1% in PTH-treated women compared with placebo (P = 0.03). Vertebral trabecular volumetric BMD increased 3.8% in PTH-treated women compared with placebo group (P = 0.08). PTH-treated women also had higher distal radial trabecular bone volume, number, and thickness compared with placebo-treated women (P < 0.04). After 1 month of daily PTH, N-terminal propeptide of type I collagen (P1NP) was markedly increased compared with placebo (P < 0 .0001), and a difference persisted, although lessened, throughout the study. Bone resorption indices were unchanged in PTH-treated women and were reduced in the placebo group. CONCLUSION: Once-weekly PTH after 1 month of daily treatment increases spine BMD, radial trabecular bone, and bone formation markers in postmenopausal women. These results suggest that less frequent alternatives to daily PTH dosing for 2 yr could be effective. Additional studies are required to define the optimal frequency of PTH administration. SN - 0021-972X UR - https://www.unboundmedicine.com/medline/citation/18349061/Randomized_trial_of_once_weekly_parathyroid_hormone__1_84__on_bone_mineral_density_and_remodeling_ L2 - https://academic.oup.com/jcem/article-lookup/doi/10.1210/jc.2007-2781 DB - PRIME DP - Unbound Medicine ER -