Study Stopped
company and Sheba did not reach an agreement
Bone Density in Children With IBD Treated With Amorphous Calcium or Commercial Crystalline Calcium
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
Patients diagnosed with, or in risk of osteoporosis regularly take calcium dietary supplements, although their contribution to BMD maintenance, prevention of bone loss or reduction of the risk of fracture is questionable. Freshwater crayfish rely on amorphous calcium carbonate (ACC), a thermodynamically instable and very rare biomineralized polymorph of calcium carbonate, as the main mineral in the exoskeleton and in their temporary storage organ, the gastrolith. The study hypothesis is that amorphous calcium carbonate (ACC) will have an advantage over calcium carbonate in improving BMD of pediatric IBD patients with reduced BMD. The investigators will include children 10-18 years old with IBD and reduced bone density to recieve regular calcium or amorphic calcium for 12 months with follow up of bone density and confounders as disease activity and medications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2015
CompletedFirst Posted
Study publicly available on registry
June 12, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 18, 2020
March 1, 2020
2 years
June 10, 2015
March 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The primary efficacy endpoint is improvement of spine bone density by 0.5 points in Z -score after 12 months
12 months
Secondary Outcomes (1)
Improvement of spine bone density by at least 0.25 points in Z -score after 12 months
12 months
Study Arms (2)
Study group
EXPERIMENTALChildren recieving DENSITYTM caplets (marketed as Amorphical) 200 mg BID for 12 months
Control group
ACTIVE COMPARATORChildren recieving Calcium carbonate 600 mg once daily for 12 months
Interventions
Eligibility Criteria
You may qualify if:
- Children 10-18 years old.
- Confirmed diagnosis of IBD
- Able to swallow pills.
- Osteopenia or osteoporosis (spine Z score lower than -1.0) on baseline bone scan.
- Informed consent.
You may not qualify if:
- Inadequate bone marrow, renal or hepatic function.
- Significant concurrent disease.
- Allergy to calcium or vitamin D preparations.
- Pathologic hypercalciuria. 5. Patient non-compliance. 6. Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
Schmidt S, Mellstrom D, Norjavaara E, Sundh SV, Saalman R. Low bone mineral density in children and adolescents with inflammatory bowel disease: a population-based study from Western Sweden. Inflamm Bowel Dis. 2009 Dec;15(12):1844-50. doi: 10.1002/ibd.20962. Epub 2009 Apr 30.
PMID: 19408319BACKGROUNDSylvester FA, Wyzga N, Hyams JS, Davis PM, Lerer T, Vance K, Hawker G, Griffiths AM. Natural history of bone metabolism and bone mineral density in children with inflammatory bowel disease. Inflamm Bowel Dis. 2007 Jan;13(1):42-50. doi: 10.1002/ibd.20006.
PMID: 17206638BACKGROUNDSchmidt S, Mellstrom D, Norjavaara E, Sundh V, Saalman R. Longitudinal assessment of bone mineral density in children and adolescents with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2012 Nov;55(5):511-8. doi: 10.1097/MPG.0b013e31825817a0.
PMID: 22688562BACKGROUNDWong SC, Catto-Smith AG, Zacharin M. Pathological fractures in paediatric patients with inflammatory bowel disease. Eur J Pediatr. 2014 Feb;173(2):141-51. doi: 10.1007/s00431-013-2174-5. Epub 2013 Oct 17.
PMID: 24132387BACKGROUNDShaltiel, G., Bar-David, E., Meiron, O. E., et al. Bone loss prevention in ovariectomized rats using stable amorphous calcium carbonate. Health 2013; 5 (7A2): 18-29
RESULTVaisman N, Shaltiel G, Daniely M, Meiron OE, Shechter A, Abrams SA, Niv E, Shapira Y, Sagi A. Increased calcium absorption from synthetic stable amorphous calcium carbonate: double-blind randomized crossover clinical trial in postmenopausal women. J Bone Miner Res. 2014 Oct;29(10):2203-9. doi: 10.1002/jbmr.2255.
PMID: 24753014RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Batia Weiss, MD
Sheba Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Pediatric Gastroenterology and Nutrition Unit
Study Record Dates
First Submitted
June 10, 2015
First Posted
June 12, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2017
Study Completion
December 1, 2017
Last Updated
March 18, 2020
Record last verified: 2020-03