Study Results
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Basic Information
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COMPLETED
PHASE3
171 participants
INTERVENTIONAL
2002-10-31
2007-07-31
Brief Summary
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The aim of this study, conducted on a large group of children, adolescents and young adults with CF, has been the evaluation of bone mass changes after 1 year of a simple treatment with RDA-adjusted dietary calcium plus 25-OH vitamin D supplementation, and the feasibility and efficacy of alendronate treatment (for another year) in patients not responding to calcium + 25-OH vitamin D alone.
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Detailed Description
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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 25-OH vitamin D supplements in all eligible subjects (N=171).
Phase 2 (1-year double-blind, randomized, placebo-controlled, parallel group study): the 128 subjects showing an insufficient response to calcium + 25-OH vitamin D alone (bone mass increase \<5%) at the end of Phase 1, were randomized into 2 groups and assigned to alendronate treatment (N=65) or placebo (N=63) (in addition to calcium and 25-OH vitamin D as during Phase 1).
The study has been carried out by the Coordinator's Institution (Istituto Auxologico Italiano)in collaboration with most Regional Reference Centers for CF in Italy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Alendronate
128 subjects participated in the study's Phase 2 (1-year double-blind, randomized, placebo-controlled, parallel group study).
65 subjects were randomized to this arm. Oral alendronate dose: 5 mg/day, if body weight ≤25 kg; 10 mg/day, if body weight \>25 kg.
Alendronate
As active drug, we used Alendros (Abiogen Pharma, Pisa, Italy), distributed to the patients in plain bottles and boxes (bearing only the center and patient codes).
Placebo
128 subjects participated in the study's Phase 2 (1-year double-blind, randomized, placebo-controlled, parallel group study).
63 subjects were randomized to this arm. Oral placebo (inactive pills).
Placebo
Placebo was distributed to the patients in plain bottles and boxes (bearing only the center and patient codes).
Interventions
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Alendronate
As active drug, we used Alendros (Abiogen Pharma, Pisa, Italy), distributed to the patients in plain bottles and boxes (bearing only the center and patient codes).
Placebo
Placebo was distributed to the patients in plain bottles and boxes (bearing only the center and patient codes).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* contraindications to 25-OH vitamin D or alendronate treatment
* recent transplantation
* other diseases or medications (glucocorticoids excepted) associated with bone loss.
5 Years
30 Years
ALL
No
Sponsors
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Fondazione Telethon
OTHER
Istituto Auxologico Italiano
OTHER
Responsible Party
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Maria Luisa Bianchi
MD, First level manager
Principal Investigators
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Maria Luisa Bianchi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Istituto Auxologico Italiano
Locations
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CRR Fibrosi Cistica, Divisione Gastroenterologia, Ospedale Bambin Gesù
Vatican City, , Holy See
CRR Fibrosi Cistica, Unità Operativa di Pediatria, Ospedale Misericordia
Grosseto, , Italy
CRR Fibrosi Cistica, Clinica Pediatrica, Policlinico Universitario di Messina
Messina, , Italy
Istituto Auxologico Italiano IRCCS
Milan, , Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Università degli Studi di Milano
Milan, , Italy
CRR Fibrosi Cistica, Dipartimento Pediatria, Università Federico II
Napoli, , Italy
CRR Fibrosi Cistica Adulti, Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, , Italy
CRR Fibrosi Cistica, Ospedale dei Bambini, ARNAS Civico
Palermo, , Italy
CRR Fibrosi Cistica, Dipartimento di Pediatria, Policlinico Umberto I
Roma, , Italy
CRR Fibrosi Cistica, Divisione di Pediatria, Istituto Burlo Garofolo
Trieste, , Italy
CRR Fibrosi Cistica, Azienda Ospedalierouniversitaria di Verona
Verona, , Italy
Countries
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References
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Grey AB, Ames RW, Matthews RD, Reid IR. Bone mineral density and body composition in adult patients with cystic fibrosis. Thorax. 1993 Jun;48(6):589-93. doi: 10.1136/thx.48.6.589.
Henderson RC, Madsen CD. Bone density in children and adolescents with cystic fibrosis. J Pediatr. 1996 Jan;128(1):28-34. doi: 10.1016/s0022-3476(96)70424-9.
Bhudhikanok GS, Lim J, Marcus R, Harkins A, Moss RB, Bachrach LK. Correlates of osteopenia in patients with cystic fibrosis. Pediatrics. 1996 Jan;97(1):103-11.
Baroncelli GI, De Luca F, Magazzu G, Arrigo T, Sferlazzas C, Catena C, Bertelloni S, Saggese G. Bone demineralization in cystic fibrosis: evidence of imbalance between bone formation and degradation. Pediatr Res. 1997 Mar;41(3):397-403. doi: 10.1203/00006450-199703000-00016.
Humphries IR, Allen JR, Waters DL, Howman-Giles R, Gaskin KJ. Volumetric bone mineral density in children with cystic fibrosis. Appl Radiat Isot. 1998 May-Jun;49(5-6):593-5. doi: 10.1016/s0969-8043(97)00203-0. No abstract available.
Aris RM, Renner JB, Winders AD, Buell HE, Riggs DB, Lester GE, Ontjes DA. Increased rate of fractures and severe kyphosis: sequelae of living into adulthood with cystic fibrosis. Ann Intern Med. 1998 Feb 1;128(3):186-93. doi: 10.7326/0003-4819-128-3-199802010-00004.
Bhudhikanok GS, Wang MC, Marcus R, Harkins A, Moss RB, Bachrach LK. Bone acquisition and loss in children and adults with cystic fibrosis: a longitudinal study. J Pediatr. 1998 Jul;133(1):18-27. doi: 10.1016/s0022-3476(98)70172-6.
Henderson RC, Madsen CD. Bone mineral content and body composition in children and young adults with cystic fibrosis. Pediatr Pulmonol. 1999 Feb;27(2):80-4. doi: 10.1002/(sici)1099-0496(199902)27:23.0.co;2-j.
Bianchi ML, Cimaz R, Bardare M, Zulian F, Lepore L, Boncompagni A, Galbiati E, Corona F, Luisetto G, Giuntini D, Picco P, Brandi ML, Falcini F. Efficacy and safety of alendronate for the treatment of osteoporosis in diffuse connective tissue diseases in children: a prospective multicenter study. Arthritis Rheum. 2000 Sep;43(9):1960-6. doi: 10.1002/1529-0131(200009)43:93.0.CO;2-J.
Brumsen C, Hamdy NA, Papapoulos SE. Long-term effects of bisphosphonates on the growing skeleton. Studies of young patients with severe osteoporosis. Medicine (Baltimore). 1997 Jul;76(4):266-83. doi: 10.1097/00005792-199707000-00005.
Glorieux FH, Bishop NJ, Plotkin H, Chabot G, Lanoue G, Travers R. Cyclic administration of pamidronate in children with severe osteogenesis imperfecta. N Engl J Med. 1998 Oct 1;339(14):947-52. doi: 10.1056/NEJM199810013391402.
Bianchi ML, Colombo C, Assael BM, Dubini A, Lombardo M, Quattrucci S, Bella S, Collura M, Messore B, Raia V, Poli F, Bini R, Albanese CV, De Rose V, Costantini D, Romano G, Pustorino E, Magazzu G, Bertasi S, Lucidi V, Traverso G, Coruzzo A, Grzejdziak AD. Treatment of low bone density in young people with cystic fibrosis: a multicentre, prospective, open-label observational study of calcium and calcifediol followed by a randomised placebo-controlled trial of alendronate. Lancet Respir Med. 2013 Jul;1(5):377-85. doi: 10.1016/S2213-2600(13)70064-X. Epub 2013 Jun 2.
Related Links
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Lab test information
Other Identifiers
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02A001
Identifier Type: -
Identifier Source: org_study_id
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