Condition category
Musculoskeletal Diseases
Date applied
25/04/2012
Date assigned
04/05/2012
Last edited
04/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Dr Miguel Angel Arrabal-Polo

ORCID ID

Contact details

Camino de Ronda street 143
Granada
18003
Spain
arrabalp@ono.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

The effect of alendronate in bone mineral density loss and calcium stones is increased when we add thiazides and we will obtain a better response than patients only treated with alendronate.

Ethics approval

Ethics Committee of the University Hospital San Cecilio of Granada approved in January 2005

Study design

Observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Bone mineral density loss and renal calcium stones

Intervention

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 loss of bone mineral density. Patients in this group were treated for three years with alendronate sodium (70 mg/week)

Group 2 included 35 patients between 25-60 years of age diagnosed with renal calcium lithiasis (moderate or severe lithiasic disease), hypercalciuria and loss of bone mineral density; patients in this group were treated for three years with alendronate sodium (70 mg/week) and hydrochlorothiazide (50 mg/day).

Intervention type

Drug

Phase

Not Applicable

Drug names

Alendronate sodium, hydrochlorothiazide

Primary outcome measures

1. Each patient´s medical history was taken, a physical examination was performed and the patient’s weight, height, body mass index and blood pressure were measured and recorded
2. Abdominal radiography and intravenous urography and/or ultrasound were 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 was begun.
3. Analysis of calculi was performed in all cases
4. Blood and urine biochemistries were performed at baseline and at six months and two years
5. Plasma levels of the following variables were studied: 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

1. Bone mineral density 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 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. Possible side effects were measured every six months in both groups

Overall trial start date

01/06/2005

Overall trial end date

01/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant 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

Recruitment start date

01/06/2005

Recruitment end date

01/06/2008

Locations

Countries of recruitment

Spain

Trial participating centre

Camino de Ronda street 143
Granada
18003
Spain

Sponsor information

Organisation

San Cecilio University Hospital (UK)

Sponsor details

Avenida Doctor Oloriz
Granada
18012
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

San Cecilio University Hospital (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes