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The Effect of Low Dose Hormone Replacement Therapy or Raloxifene on Bone and Lipid Metabolism in Hemodialysis Patients

The Effect of Low Dose Hormone Replacement Therapy or Raloxifene on Bone and Lipid Metabolism in Hemodialysis Patients - Low Dose HRT and Raloxifene Trial in Hemodialysis Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000390
Enrollment
39
Registered
2006-04-01
Start date
2004-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal osteopenia in hemodialysis patients

Interventions

Transdermal low dose estrogen replacement therapy with cyclic administration of medroxyprogesterone acetate at 3-month interval Oral administration of raloxifene every two days No drug intervention

Sponsors

Department of Nephrology, Osaka University School of Medicine
Lead Sponsor
Dai-Ni Rokushima Clinic Imai Naika Clinic Obi Clinic
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Postmenopausal hemodialysis patients with prevalent fracture or with a T-score of radial bone mineral density <-1.0 on the side without atrio-venous fistula.

Exclusion criteria

Exclusion criteria: 1. Patients with arteriosclerosis obliterans 2. Patients at high risk of venous thrombosis. i.e. bedridden patients 3. Patients with history of uterine cancer and/or breast cancer. 4. Patients receiving specific treatments other than active vitamin D that affect bone and mineral metabolism. i.e. calcitonin, bisphosphonate, and recombinant human PTH.

Design outcomes

Primary

MeasureTime frame
Changes in serum calcium, phosphorus, parathyroid hormone, bone markers and lipid metabolism

Secondary

MeasureTime frame
Change in bone mineral density at the radius on the side without atrio-venous fistula

Countries

Japan

Contacts

Public ContactTakahito Ito

Osaka University School of Medicine Department of Nephrology

taka@medone.med.osaka-u.ac.jp06-6879-3632

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026