drugset / Trial / NCT01928082
The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to assess if estrogen replacement normalizes urinary calcium excretion in postmenopausal women with hypercalciuria and low bone mass and to assess for differences in response to estrogen replacement in women with familial hypercalciuria compared to nonfamilial hypercalciuria.
Timeline
- Start
- 2013-08-01
- Primary completion
- 2014-08-01
- Completion
- 2014-08-01
Publications
- Background Cerda Gabaroi D, Peris P, Monegal A, Albaladejo C, Martinez MA, Muxi A, Martinez de Osaba MJ, Suris X, Guanabens N. Search for hidden secondary causes in postmenopausal women with osteoporosis. Menopause. 2010 Jan-Feb;17(1):135-9. doi: 10.1097/gme.0b013e3181ade8e5.
- Background Christiansen C, Riis BJ, Rodbro P. Prediction of rapid bone loss in postmenopausal women. Lancet. 1987 May 16;1(8542):1105-8. doi: 10.1016/s0140-6736(87)91671-0.
- Background Deutschmann HA, Weger M, Weger W, Kotanko P, Deutschmann MJ, Skrabal F. Search for occult secondary osteoporosis: impact of identified possible risk factors on bone mineral density. J Intern Med. 2002 Nov;252(5):389-97. doi: 10.1046/j.1365-2796.2002.01040.x.
- Background Favus MJ, Karnauskas AJ, Parks JH, Coe FL. Peripheral blood monocyte vitamin D receptor levels are elevated in patients with idiopathic hypercalciuria. J Clin Endocrinol Metab. 2004 Oct;89(10):4937-43. doi: 10.1210/jc.2004-0412.
- Background Frumar AM, Meldrum DR, Geola F, Shamonki IM, Tataryn IV, Deftos LJ, Judd HL. Relationship of fasting urinary calcium to circulating estrogen and body weight in postmenopausal women. J Clin Endocrinol Metab. 1980 Jan;50(1):70-5. doi: 10.1210/jcem-50-1-70.
- Background Giannini S, Nobile M, Dalle Carbonare L, Lodetti MG, Sella S, Vittadello G, Minicuci N, Crepaldi G. Hypercalciuria is a common and important finding in postmenopausal women with osteoporosis. Eur J Endocrinol. 2003 Sep;149(3):209-13. doi: 10.1530/eje.0.1490209.
- Background Lobo RA, Roy S, Shoupe D, Endres DB, Adams JS, Rude RK, Singer FR. Estrogen and progestin effects on urinary calcium and calciotropic hormones in surgically-induced postmenopausal women. Horm Metab Res. 1985 Jul;17(7):370-3. doi: 10.1055/s-2007-1013545.
- Background McKane WR, Khosla S, Burritt MF, Kao PC, Wilson DM, Ory SJ, Riggs BL. Mechanism of renal calcium conservation with estrogen replacement therapy in women in early postmenopause--a clinical research center study. J Clin Endocrinol Metab. 1995 Dec;80(12):3458-64. doi: 10.1210/jcem.80.12.8530583.
- Background Nordin BE, Horowitz M, Need A, Morris HA. Renal leak of calcium in post-menopausal osteoporosis. Clin Endocrinol (Oxf). 1994 Jul;41(1):41-5. doi: 10.1111/j.1365-2265.1994.tb03782.x.
- Background Nordin BE, WIshart JM, Clifton PM, McArthur R, Scopacasa F, Need AG, Morris HA, O'Loughlin PD, Horowitz M. A longitudinal study of bone-related biochemical changes at the menopause. Clin Endocrinol (Oxf). 2004 Jul;61(1):123-30. doi: 10.1111/j.1365-2265.2004.02066.x.
- Background Nordin BE, Need AG, Morris HA, Horowitz M. Biochemical variables in pre- and postmenopausal women: reconciling the calcium and estrogen hypotheses. Osteoporos Int. 1999;9(4):351-7. doi: 10.1007/s001980050158.
- Background Nordin BE, Need AG, Morris HA, Horowitz M, Robertson WG. Evidence for a renal calcium leak in postmenopausal women. J Clin Endocrinol Metab. 1991 Feb;72(2):401-7. doi: 10.1210/jcem-72-2-401.
- Background Puche RC, Roveri E, Perez Jimeno N, Roberti A, Poudes G, Bocanera R, Tozzini R. Hypercalciuria and urinary saturation measurements in climacteric women. Maturitas. 1993 Jan;16(1):39-47. doi: 10.1016/0378-5122(93)90132-2.
- Background Stock JL, Coderre JA, Mallette LE. Effects of a short course of estrogen on mineral metabolism in postmenopausal women. J Clin Endocrinol Metab. 1985 Oct;61(4):595-600. doi: 10.1210/jcem-61-4-595.
- Background Voetberg GA, Netelenbos JC, Kenemans P, Peters-Muller ER, van de Weijer PH. Estrogen replacement therapy continuously combined with four different dosages of dydrogesterone: effect on calcium and lipid metabolism. J Clin Endocrinol Metab. 1994 Nov;79(5):1465-9. doi: 10.1210/jcem.79.5.7962344.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 0.1 mg | Other |