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Reply To the Editors: We appreciate many of the comments of Prior et al regarding our randomized trial to evaluate the bone effects of progesterone and progestins in early menopausal women. 1 We agree that increased bone resorption is the principal reason for loss in bone density during the early menopausal period. However, this process cannot be compensated by the bone formation action of progestins alone. The addition of an antiresorptive agent such as estradiol to control resorption may uncover the bone promoting effects MPA such that the combination of E+MPA may be greater than E alone, but this failed to reach statistical significance between the 2 groups in our study because of a smaller number of subjects. With regards to their concern that the trial is inadequately analyzed and reported we respectfully disagree. 1) We have followed the CONSORT guidelines, and a CONSORT type flow diagram of the randomization and follow-up are provided for the entire study. 2 2) The analysis of BMD endpoints as a percentage change from baseline is an appropriate approach to evaluate BMD changes in the same subject. The use of absolute within-woman BMD change does not add additional information. 3) Although major adverse http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png American Journal of Obstetrics and Gynecology Wolters Kluwer Health

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Publisher
Wolters Kluwer Health
Copyright
Copyright © 2006 Mosby, Inc.
ISSN
0002-9378
DOI
10.1016/j.ajog.2005.10.200
Publisher site
See Article on Publisher Site

Abstract

To the Editors: We appreciate many of the comments of Prior et al regarding our randomized trial to evaluate the bone effects of progesterone and progestins in early menopausal women. 1 We agree that increased bone resorption is the principal reason for loss in bone density during the early menopausal period. However, this process cannot be compensated by the bone formation action of progestins alone. The addition of an antiresorptive agent such as estradiol to control resorption may uncover the bone promoting effects MPA such that the combination of E+MPA may be greater than E alone, but this failed to reach statistical significance between the 2 groups in our study because of a smaller number of subjects. With regards to their concern that the trial is inadequately analyzed and reported we respectfully disagree. 1) We have followed the CONSORT guidelines, and a CONSORT type flow diagram of the randomization and follow-up are provided for the entire study. 2 2) The analysis of BMD endpoints as a percentage change from baseline is an appropriate approach to evaluate BMD changes in the same subject. The use of absolute within-woman BMD change does not add additional information. 3) Although major adverse

Journal

American Journal of Obstetrics and Gynecology – Wolters Kluwer Health

Published: May 1, 2006

References

  • The effects of prgestins on bone density and bone metabolism in postmenopausal women: a randomized controlled trial
    Liu, J.H.; Muse, K.N.
  • The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials
    Moher, D.; Schulz, K.F.; Altman, D.G.; CONSORT
  • Effect of lower doses of conjugated equine estrogens with and without medroxyprogesterone acetate on bone in early postmenopausal women
    Lindsay, R.; Gallagher, J.C.; Kleerkoper, M.; Pickar, J.H.
  • Prevention of bone loss with tibolone in postmenopausal women: results of two randomized, double-blind, placebo-controlled, dose-finding studies
    Gallagher, J.; Baylink, D.J.; McClung, M.