Condition category
Musculoskeletal Diseases
Date applied
25/04/2012
Date assigned
04/05/2012
Last edited
25/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Kidney stones (renal calcium lithiasis) form if there's too much calcium in the urine (hypercalciuria), and can block the urinary system and cause severe pain. Osteopenia/osteoporosis are conditions where bone density is decreased, making them fragile and more likely to break. The aim of this study is to assess the effects of a combination of drugs (alendronate and hydrochlorothiazide) on patients with renal calcium lithiasis, hypercalciuria and osteopenia/osteoporosis .

Who can participate?
Patients aged between 25 and 60 with renal calcium lithiasis, hypercalciuria and osteopenia/osteoporosis

What does the study involve?
Participants are treated with either alendronate or alendronate and hydrochlorothiazide for 3 years. At the start of the study each participant’s medical history is taken, a physical examination is performed and the participant’s weight, height and blood pressure are measured. X-ray and/or ultrasound scans are performed to check for kidney stones at the start of the study and every 6 months. Blood and urine samples are taken at the start of the study and after 6 months and 2 years. Bone mineral density is assessed at the start of the study and after 2 years of treatment using a DEXA scan (a type of x-ray). Side effects are measured every 6 months.

What are the possible benefits and risks of participating?
The possible benefits of the study are improvement of bone mineral density and stabilization of kidney stone disease. The risks are those arising from the side effects of the drugs such as low blood pressure, electrolyte (blood salt level) disturbances or esophagitis (inflammation of the gullet), which occur in a very low number of patients.

Where is the study run from?
San Cecilio University Hospital (Spain)

When is the study starting and how long is it expected to run for?
June 2005 to June 2008

Who is funding the study?
San Cecilio University Hospital (Spain)

Who is the main contact?
Dr Miguel Angel Arrabal-Polo
arrabalp@ono.com

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, January 2005

Study design

Observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details 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 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 outcome measures

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

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 (Spain)

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

25/04/2017: Plain English summary added.