Home » Trials » SLCTR/2018/038


Effect of alendronate and vitamin D on selected bone turnover markers in women with postmenopausal osteoporosis and a high fracture risk; a randomized controlled trial -

SLCTR Registration Number

SLCTR/2018/038


Date of Registration

14 Nov 2018

The date of last modification

Nov 14, 2018



Application Summary


Scientific Title of Trial

Effect of alendronate and vitamin D on selected bone turnover markers in women with postmenopausal osteoporosis and a high fracture risk; a randomized controlled trial


Public Title of Trial

Effect of alendronate and vitamin D on selected bone turnover markers in women with postmenopausal osteoporosis and a high fracture risk; a randomized controlled trial


Disease of Health Condition(s) Studied

Post-menopausal osteoporosis


Scientific Acronym

None


Public Acronym

None


Brief title

Effect of bisphosphonates on bone turnover markers in postmenopausal osteoporosis.


Universal Trial Number

U1111-1223-8917


Any other number(s) assigned to the trial and issuing authority

09.03.2016: 3.17 (ERC: University of Ruhuna)


Trial Details


What is the research question being addressed?

What is the effect of alendronate verses vitamin D on selected bone turnover markers in women with postmenopausal osteoporosis and a high fracture risk?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Purpose


Intervention(s) planned

  1. Post-menopausal women will be recruited from Bope-Poddala MOH area in Galle using latest electoral registers.

  2. Participants who fulfill the eligibility criteria with high fracture risk will be randomly assigned into two groups (Treatment group and Control group) by block randomization method (one block will consist of two participants)

  3. Treatment group will receive oral alendronate (70 mg/week) with oral vitamin D3 (800IU/day) for 6 months.

  4. Control group will receive a placebo prepared similar to the alendronate tablet along with vitamin D3 (800IU/day) for 6 months.

  5. Study participants, clinicians and data collectors/analysts will be blinded to the intervention


Inclusion criteria

  1. Newly diagnosed post-menopausal females with high fracture risk. Fracture risk assessment: The fracture risk will be assessed based on FRAX algorithm using clinical risk factors and bone mineral density values. Women with major fracture risk >10% and/or hip fracture risk >3% will be considered to have a high fracture risk. Lekamwasam S, (2013), Sri Lankan FRAX model and country-specific intervention thresholds. Arch Osteoporos;8:148.

Exclusion criteria

  1. Females with a history of significant neuroendocrine disorder that affect the BTMs (disorders of thyroid gland like hyperthyroidism and disorders of parathyroid glands such as hyperparathyroidism and hypoparathyroidism)
  2. Treatment with anticonvulsant, thyroxin and hydrochlorothiazide that affect the vitamin D and calcium metabolism
  3. Chronic kidney disease stage 4 or 5 (when eGFR is less than <30 mL min-1 per 1.73 m2)
  4. Chronic liver disease (clinically evident)
  5. Other metabolic or inherited bone diseases other than postmenopausal bone loss including Paget’s disease and osteomalacia
  6. Rheumatoid arthritis or collagen disease
  7. Subjects with malignancies
  8. Immobilized or disabled subjects due to cerebrovascular disease
  9. Gastric surgery, major gastrointestinal disease that causes significant malabsorption,
  10. Use of any systemic steroid (prednisolone, dexamethasone or equivalent),
  11. Use of bisphosphonates within the year directly preceding the study
  12. Other anti-osteoporotic drugs (selective oestrogen receptor modulators and calcitonin) and calcium, vitamin supplement during the last three months
  13. Women who have experienced early menopause (before 45 years of age)
  14. Women who have undergone any therapy which can affect the bone metabolism (hormone replacement therapy andandrogen-stimulating therapy)
  15. Women who are known to take antipsychotics and antiepileptic sodium valproate
  16. Fracture during the last one year
  17. Acute illness at the time of recruitment or during last 3 months
  18. Allergy for bisphosphonates


Primary outcome(s)

Percentage reduction of the serum concentrations of selected bone turnover markers. 1) CTX (carboxy terminal telopeptide of collagen type I), 2) PINP (procollagen type I N-terminal pro-peptide)


Primary outcome(s) - Time of assessment(s)

At the baseline and at 24th week after the commencement of the intervention.


Secondary outcome

Tolerability measured by the rate of "dropouts" due to the adverse effects of alendronate

Adverse effects of medications - upper GI tract symptoms (i.e. abdominal pain, nausea, vomiting


Secondary outcome(s) - Time of assessment(s)

At the 24th week after commencement of the intervention.



Target number/sample size

60 (30 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2019-01-01


Anticipated end date

2019-11-01


Recruitment status

Pending


State of ethics review approval

Approved by the ERC, Faculty of Medicine, University of Ruhuna (Ref: 09.03.2016: 3.17) Extension date: 22.03. 2017


Funding source

UGC Special Allocation for Strengthening Research (RU/PG-R/16/02)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Mrs. M R P Hasanga
Lecturer (Probationary)
Department of Biochemistry Faculty of Medicine, University of Ruhuna, Galle
091 2234801
0718154005
0912222314
hasangamr@gmail.com

Contact Person for Public Queries

Professor Sarath Lekamwasam
Senior Professor of Medicine
Department of Medicine Faculty of Medicine,University of Ruhuna, Galle
091 2234801,091 2234803
0777275360
091 2222314
slekamwasam@gmail.com


Primary study sponsor/organization


The Dean
Faculty of Graduate Studies, University of Ruhuna, Wellamadama, Matara
041-2222681, 041-2222682
041-2227001

Secondary study sponsor (If any)