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Effects of aminobisphosphonates and thiazides in patients with osteopenia / osteoporosis, hypercalciuria and recurring renal calcium lithiasis

Effects of aminobisphosphonates and thiazides in patients with osteopenia/osteoporosis, hypercalciuria and recurring renal calcium lithiasis: an observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN70158709
Enrollment
70
Registered
2012-05-04
Start date
2005-06-01
Completion date
Unknown
Last updated
2017-05-22

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

Conditions

Bone mineral density loss and renal calcium stones Musculoskeletal Diseases Other osteoporosis

Interventions

The patients were divided into two groups: Group 1 included 35 patients between 25-60 years of age diagnosed with renal calcium lithiasis (moderate or severe lithiasic disease), hypercalciuria and lo
patients in this group were treated for three years with alendronate sodium (70 mg/week) and hydrochlorothiazide (50 mg/day).

Sponsors

San Cecilio University Hospital (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Men and women 25-60 years of age with moderate or severe lithiasic disease and bone mineral density loss

Exclusion criteria

Exclusion criteria: 1. Patients> 60 or <25 years 2. Patients with congenital bone disease 3. Congenital renal disease 4. Hyperparathyroidism 5. Inflammatory bowel disease or renal tubular acidosis and 6. Patients undergoing hormone replacement therapy or treatment with corticosteroids, calcium and/or vitamin D

Design outcomes

Primary

MeasureTime frame
1. Each patient's medical history is taken, a physical examination is performed and the patient'?s weight, height, body mass index and blood pressure are measured and recorded 2. Abdominal radiography and intravenous urography and/or ultrasound performed at the outset of the study to evaluate the presence or absence of calcium lithiasis and the size of lithiasic residues before medical treatment begins 3. Analysis of calculi performed in all cases 4. Blood and urine biochemistries performed at baseline and at six months and two years 5. Plasma levels of the following variables: glucose, creatinine, urea, uric acid, sodium, potassium, chloride, calcium, phosphorus, alkaline phosphatase, intact parathyroid hormone (iPTH), osteocalcin, beta-crosslaps, beta-crosslaps/osteocalcin and vitamin 1-25 OH-D. The 24-hour urine study included diuresis, creatinine clearance, creatinine, calcium, phosphorus, uric acid, oxalate, citrate, magnesium and the calcium/citrate ratio

Secondary

MeasureTime frame
1. Bone mineral density, measured at baseline and at two years of treatment. Bone densitometry was performed by dual-energy x-ray absorptiometry using a Hologic QDR 4500. At the onset of the study, patients were classified as calcium lithiasic formers with moderate or severe lithiasic disease based on the changes that had occurred over the previous three years 2. Growth of residual lithiasis and relapsing lithiasis, measured by means of an ordinary X-ray of the urinary system performed every six months. At the end of the three-year study, the degree of relapse was determined as well as whether there had been lithiasic growth or decrease due to spontaneous excretion present at the onset of treatment 3. Side effects, measured every six months

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026