Last reviewed · How we verify
NCT01656512
Analysis of Outcome of Bisphosphonate Use in Children With ALL- "Case Controlled Study"
Phase 3 trial testing zolendronic acid in Osteoporosis in 95 participants. Completed in 1 August 2015.
1 January 2014
Quick facts
| Lead sponsor | Children's Cancer Hospital Egypt 57357 |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 95 |
| Start date | 1 October 2011 |
| Primary completion | 1 January 2014 |
| Estimated completion | 1 August 2015 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- zolendronic acid — full drug profile →
- calcium & vitamin D
Conditions studied
- Osteoporosis — all drugs for Osteoporosis →
Sponsor
Children's Cancer Hospital Egypt 57357
Who can join
Adults 5 to 18, any sex, with Osteoporosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Measure the change in the Bone densitometry due to secondary osteoporosis
Time frame: 1- At baseline ( not more than 48 hours of start of therapy with steroids) 2- At week 48 3- At end of treatment ( week 120 for girls ) & ( week 146 for boys) 4-As required clinically eg: fractures .
we will do the following for evaluation : 1. Bone densitometry using Dual-energy x-ray absorptiometry (DXA) scan analyzed using the Z-score. To be done : * At baseline ( not more than 48 hours of start of therapy with steroids) * At week 48 * At end of treatment ( week 120 for girls ) \& ( week 146 for boys) * As required clinically eg: fractures . 2. Magnetic resonance imaging of bo
Sponsor's own description
Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for one fourth of all childhood cancers \& 74 % of childhood leukemia. Based upon drug registry data, children prescribed more than three courses of systemic glucocorticoids yearly faced a 20% increase in age-adjusted fracture rates. Rapid recovery occurred once glucocorticoids were discontinued, and fracture rates returned to expected for age by 1 year after treatment (Journal Of Clinical Endocrinology \& Metabolism 2009). The investigators will study the role of bisphosphonates in the prevention of secondary osteoporosis in children \& adolescents treated for ALL in the Children's Cancer Hospital -Egypt.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01656512
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Osteoporosis
Currently open trials in the same condition.
- NCT07027306 — The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fract · recruiting
- NCT07367776 — Patient Education in Osteoporosis (RCT-PATOS) · NA · recruiting
- NCT06731608 — OsteoPorotic fracTure preventION System (OPTIONS) Research Study · NA · recruiting
- NCT07281586 — Step-down Therapy After Long-term Osteoporosis Treatment · Phase 4 · recruiting
- NCT07083557 — Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiome · recruiting
Other Children's Cancer Hospital Egypt 57357 trials
Trials by the same sponsor.
- NCT05452668 — Laser Therapy Effect on Oral Mucositis in Childhood Acute Lymphoblastic Leukemia Patients · NA · unknown
- NCT06267417 — Laser Therapy Effect as Preventive Measure for Oral Mucositis in Children With Hematological Malignancies · NA · completed
- NCT05493228 — Dexmedetomidine Infusion on Intraoperative Propofol,Fentanyl Requirements in Spine Surgery for Pediatric Cancer Patients · Phase 3 · unknown
- NCT05024253 — Perioperative Use of Tranexamic (TXA) in Bone Tumor Surgery Will Change in Blood Loss and Transfusion Requirements. · Phase 3 · completed
- NCT04860934 — Dual Task Training On Children With Ataxia After Medulloblastoma Resection · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01656512 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Cancer Hospital Egypt 57357
- Last refreshed: 15 April 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01656512.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing