A Phase 2 interventional study of Transdermal estradiol in Hypercalciuria, Hypercalciuria, Familial Idiopathic and Osteopenia, sponsored by University of Chicago. Terminated at 1 site in United States. Open to female participants aged 40 Years to 69 Years. Per ClinicalTrials.gov, last updated 2018-12-10.
Sponsored by University of Chicago · Phase 2, Interventional, and Treatment
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.
Subjects will primarily be recruited from the subjects of protocol 12-1421. Subjects may also be identified through chart review of patients seen by Dr. Favus in the Bone Clinic at the University of Chicago. These subjects will be mailed a letter describing the study and a request to contact us if they are willing to participate in the study.
We plan to enroll 20 subjects to obtain complete data on 16 subjects. We aim to have 10 subjects who will have confirmed familial idiopathic hypercalciuria (IH) and 10 subjects who will have no family history of hypercalciuria.
Subjects will be brought into the Clinical Research Center at the University of Chicago where blood samples will be collected by phlebotomy to obtain the following screening tests: complete metabolic panel; including calcium, phosphate, magnesium, creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and albumin; parathyroid hormone, 25-hydroxyvitamin D, follicle stimulating hormone (FSH), and estradiol. A twenty-four hour urine collection starting with second void of the day will be collected for calcium, phosphate, magnesium, citrate, oxalate, sodium, ammonia, sulfate, and creatinine. Subjects on diuretics will be screened after a 2 week washout period, provided this can be discontinued safely. If subjects have participated in study protocol number 12-1421, these screening tests do not have to be repeated and the results from protocol number 12-1421 will be used to determine eligibility.
Screening subjects who meet inclusion criteria can proceed to the observational study. Screening subjects who are vitamin D depleted (serum 25-hydroxyvitamin D less than 35 ng/mL) may be rescreened after repletion of vitamin D.
A letter describing the study aims, protocols, and risks and benefits will be sent to their primary care physicians and gynecologists. Upon completion of the study, a summary letter will be sent as well.
Prior to the baseline visit a twenty-four hour urine collection starting with the second void of the day will be collected for calcium, phosphate, magnesium, citrate, oxalate, sodium, ammonia, sulfate, and creatinine. Subjects on diuretics will require a 2 week washout period, provided this can be discontinued safely. During the baseline visit a medical history will be taken and a physical exam will be performed. Venous blood will be collected for 1,25-dihydroxyvitamin D3, osteocalcin, bone-specific alkaline phosphatase, C-telopeptides of type 1 collagen (CTX), procollagen type 1 N-terminal propeptide (P1NP), bone morphogenetic protein 2 (BMP-2), and sclerostin. If the subject has had these blood tests performed in the preceding four months for protocol 12-1421, the blood tests will not be repeated. 18F sodium fluoride PET/CT bone scan will be performed. The protocol for the radionuclide imaging is attached.
All subjects will be started on transdermal 17-beta-estradiol 0.05 mg/d, which is equivalent to the standard dose of conjugated estrogen dose of 0.625 mg, for 4 weeks and increased to 0.1 mg for subsequent 4 weeks. Given the short duration of this study, progesterone will not be provided, as 8 weeks is not of sufficient duration to significantly increase the risk of endometrial cancer (Strom, Schinnar et al. 2006).
For the entire study, diuretics will be discontinued if it has been deemed safe to do so by the principle investigator or prescribing physician. Throughout the study, subject will maintain 900-1200 mg of dietary calcium daily. To monitor dietary calcium intake, a 5 day diet diary will be kept from Sunday to Thursday of the fourth week of each medication dose. Compliance of the study medication will be assessed by estrogen patch counts.
The following blood tests will be repeated 4 and 8 weeks after starting estradiol patch: complete metabolic panel (including calcium, phosphate, potassium, bicarbonate, chloride, magnesium, creatinine, and albumin), 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D3, parathyroid hormone, estradiol, osteocalcin, bone-specific alkaline phosphatase, C-telopeptides of type 1 collagen (CTX), procollagen type 1 N-terminal propeptide (P1NP), bone morphogenetic protein 2 (BMP-2), and sclerostin. In addition, 4 and 8 weeks after starting estradiol patch, 24 hour urine collection will be performed for calcium, phosphate, magnesium, citrate, oxalate, sodium, ammonia, sulfate, and creatinine.
33 studies on the registry are indexed under Hypercalciuria; 4 are open to participants now.
This study's enrollment of 1 is below the median of 40 across 25 interventional studies indexed under Hypercalciuria.
Browse Hypercalciuria studies →University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transdermal estradiol 0.05 mg/day for 4 weeks, followed by 0.10 mg/day for 4 weeks
Drug: Transdermal estradiol
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
Absolute Change in 24 Hour Urinary Calcium Excretion
0 participants were measured because the study was terminated
Time frame: 4 weeks, 8 weeks
Serum 1,25-dihydroxyvitamin D3
0 participants were analyzed because the study was terminated
Time frame: 4 weeks, 8 weeks
Serum Bone Morphogenetic Protein 2
Not available because the study was terminated
Time frame: 4 weeks, 8 weeks
Serum Sclerostin
Not available because the study was terminated
Time frame: 4 weeks, 8 weeks
Serum Estradiol
Not available because the study was terminated
Time frame: 4 weeks, 8 weeks
Serum Total Calcium
Not available because the study was terminated
Time frame: 4 weeks, 8 weeks
Calculated Serum Ionized Calcium
Not available because the study was terminated
Time frame: 4 weeks, 8 weeks
Calculated Tubular Resorption of Calcium
Not available because the study was terminated
Time frame: 4 weeks, 8 weeks
Serum 25 Hydroxyvitamin D
Not available because the study was terminated
Time frame: 4 weeks, 8 weeks
Serum Parathyroid Hormone
Not available because the study was terminated
Time frame: 4 weeks, 8 weeks
Serum Phosphorus
Not available because the study was terminated
Time frame: 4 weeks, 8 weeks
Serum Osteocalcin
Not available because the study was terminated
Time frame: 4 weeks, 8 weeks
Serum Bone-specific Alkaline Phosphatase
Not available because the study was terminated
Time frame: 4 weeks, 8 weeks
Serum C-telopeptides of Type 1 Collagen
Not available because the study was terminated
Time frame: 4 weeks, 8 weeks
Serum Procollagen Type 1 N-terminal Propeptide
It is not available because the study was terminated
Time frame: 4 weeks, 8 weeks
| Milestone | Transdermal Estradiol |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
| Withdrew: Study terminated. | 1 |
0 participants were measured because the study was terminated
No measurements were reported for this outcome.
0 participants were analyzed because the study was terminated
No measurements were reported for this outcome.
Not available because the study was terminated
No measurements were reported for this outcome.
Not available because the study was terminated
No measurements were reported for this outcome.
Not available because the study was terminated
No measurements were reported for this outcome.
Not available because the study was terminated
No measurements were reported for this outcome.
Not available because the study was terminated
No measurements were reported for this outcome.
Not available because the study was terminated
No measurements were reported for this outcome.
Not available because the study was terminated
No measurements were reported for this outcome.
Not available because the study was terminated
No measurements were reported for this outcome.
Not available because the study was terminated
No measurements were reported for this outcome.
Not available because the study was terminated
No measurements were reported for this outcome.
Not available because the study was terminated
No measurements were reported for this outcome.
Not available because the study was terminated
No measurements were reported for this outcome.
It is not available because the study was terminated
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transdermal Estradiol | — | — | — |
data were not collected
| Age, Continuous | Transdermal Estradiol |
|---|
| Sex: Female, Male | Transdermal Estradiol |
|---|---|
| Female | — |
| Male | — |
| Race and Ethnicity Not Collected | Transdermal Estradiol |
|---|
Ran from Aug 2013 to primary completion in Aug 2014, 12 months.
Results were first posted in Mar 2018, 3 years 7 months after primary completion.
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This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Estradiol