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

Not Applicable

Completed

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

Registration Number: ISRCTN70158709

Lead Sponsor: San Cecilio University Hospital (Spain)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 70

Inclusion Criteria

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

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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<br>3. Analysis of calculi performed in all cases<br>4. Blood and urine biochemistries performed at baseline and at six months and two years<br>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 Outcome Measures

Name	Time	Method
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<br>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<br>3. Side effects, measured every six months