Status:
COMPLETED
Treatment of Low Bone Density in Cystic Fibrosis.
Lead Sponsor:
Istituto Auxologico Italiano
Collaborating Sponsors:
Fondazione Telethon
Conditions:
Osteoporosis
Cystic Fibrosis
Eligibility:
All Genders
5-30 years
Phase:
PHASE3
Brief Summary
Cystic fibrosis (CF) -- an autosomal recessive genetic disease affecting about 60,000 individuals worldwide, including about 3,800 in Italy -- is often associated with low bone mineral mass. The curre...
Detailed Description
The study included 2 phases. Phase 1 (1-year open-label observational study): following baseline evaluation, bone mass changes have been studied with a simple therapy of adequate calcium intake and 2...
Eligibility Criteria
Inclusion
- age 2-30 years
- clinically stable condition
- regular menses in females
- low Bone Mineral Apparent Density for age (defined as BMAD Z-score ≤-2.0 if age ≤18 years or ≤-2.5 if age \>18 years).
Exclusion
- two or more episodes of hypercalcemia and/or hypercalciuria
- contraindications to 25-OH vitamin D or alendronate treatment
- recent transplantation
- other diseases or medications (glucocorticoids excepted) associated with bone loss.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT01812551
Start Date
October 1 2002
End Date
July 1 2007
Last Update
March 6 2014
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
CRR Fibrosi Cistica, Divisione Gastroenterologia, Ospedale Bambin Gesù
Vatican City, Holy See
2
CRR Fibrosi Cistica, Unità Operativa di Pediatria, Ospedale Misericordia
Grosseto, Italy
3
CRR Fibrosi Cistica, Clinica Pediatrica, Policlinico Universitario di Messina
Messina, Italy
4
Istituto Auxologico Italiano IRCCS
Milan, Italy, 20145