NCT01928082

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

March 7, 2018

Completed
Last Updated

December 10, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

August 20, 2013

Results QC Date

October 12, 2017

Last Update Submit

December 7, 2018

Conditions

HypercalciuriaHypercalciuria, Familial IdiopathicOsteopeniaOsteoporosis

Keywords

Hypercalciuria, Familial IdiopathicHypercalciuriaOsteopeniaOsteoporosisPostmenopausal women

Outcome Measures

Primary Outcomes (1)

  • Absolute Change in 24 Hour Urinary Calcium Excretion

    0 participants were measured because the study was terminated

    4 weeks, 8 weeks

Secondary Outcomes (3)

  • Serum 1,25-dihydroxyvitamin D3

    4 weeks, 8 weeks

  • Serum Bone Morphogenetic Protein 2

    4 weeks, 8 weeks

  • Serum Sclerostin

    4 weeks, 8 weeks

Other Outcomes (11)

  • Serum Estradiol

    4 weeks, 8 weeks

  • Serum Total Calcium

    4 weeks, 8 weeks

  • Calculated Serum Ionized Calcium

    4 weeks, 8 weeks

  • +8 more other outcomes

Study Arms (1)

Transdermal estradiol

EXPERIMENTAL

Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks

Drug: Transdermal estradiol

Interventions

Transdermal estradiolDRUG

4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day

Also known as: Vivelle-Dot 0.05 mg/day, Vivelle-Dot 0.10 mg/day
Transdermal estradiol

Eligibility Criteria

Age40 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women
  • Diagnosis of hypercalciuria
  • Diagnosis of low bone mass
  • Vitamin D replete (serum 25-hydroxyvitamin D level \>35 ng/mL)

You may not qualify if:

  • Secondary causes of hypercalciuria (primary hyperparathyroidism, sarcoidosis, vitamin D excess, malignant neoplasm, and renal tubular acidosis)
  • Other metabolic bone disease (primary hyperparathyroidism, hyperthyroidism, hypercortisolemia, severe gastrointestinal disorders, liver cirrhosis, renal failure (Cr \>1.5), active malignancy including multiple myeloma, rheumatological diseases, and Paget's disease of bone)
  • Use of medications affecting bone and calcium metabolism (corticosteroids in the previous 3 months, suppressive dose of thyroid hormone, calcium channel blockers, anti-convulsants, aromatase inhibitors, thiazolidinediones, and cyclosporine A)
  • History of coronary artery disease
  • Breast cancer or suspected estrogen-dependent neoplasia
  • Previous venous thromboembolic event
  • Stroke
  • Active liver disease
  • Tobacco use within the past 6 months
  • Negative colonoscopy within the previous 10 years or sigmoidoscopy within the previous 5 years
  • Negative mammogram within the previous 2 years
  • Negative Pap smear within the previous 3 years in women \< or = 65 years old with an intact cervix
  • No vaginal bleeding within the prior 5 months.
  • Age \> or = 70
  • \> or = 20 years since last menstrual period or use of hormone replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (15)

  • 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.

    PMID: 19593233BACKGROUND

  • 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.

    PMID: 2883442BACKGROUND

  • 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.

    PMID: 12528756BACKGROUND

  • 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.

    PMID: 15472188BACKGROUND

  • 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.

    PMID: 7350188BACKGROUND

  • 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.

    PMID: 12943523BACKGROUND

  • 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.

    PMID: 3161813BACKGROUND

  • 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.

    PMID: 8530583BACKGROUND

  • 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.

    PMID: 8050130BACKGROUND

  • 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.

    PMID: 15212654BACKGROUND

  • 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.

    PMID: 10550453BACKGROUND

  • 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.

    PMID: 1991810BACKGROUND

  • 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.

    PMID: 8429802BACKGROUND

  • 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.

    PMID: 2993339BACKGROUND

  • 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.

    PMID: 7962344BACKGROUND

MeSH Terms

Conditions

HypercalciuriaHypercalciuria, Absorptive, 2Bone Diseases, MetabolicOsteoporosis

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Early termination leading to 0 subjects analyzed

Results Point of Contact

Title
Murray J. Favus
Organization
The University of Chicago
mfavus@medicine.bsd.uchicago.edu
(773) 702-6138

Study Officials

  • Murray J Favus, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2013

First Posted

August 23, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 10, 2018

Results First Posted

March 7, 2018

Record last verified: 2018-10

Locations

US(1)