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Alendronate for the prevention of osteoporosis in ankylosing spondylitis

A randomized, double-blind, placebo-controlled pilot study of the efficacy of alendronate on the prevention of bone loss in patients with early ankylosing spondylitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201212206975N3
Enrollment
20
Registered
2013-01-31
Start date
2013-02-19
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing spondylitis. Ankylosing spondylitis

Interventions

Intervention 1: Control group will receive placebo for 12 months. Intervention 2: Treatment group will receive alendronate sodium 70 mg tablet (Ostomod, Modava company) with 70mg/week (one tablet at w
Treatment - Drugs
Control group will receive placebo for 12 months.
Treatment group will receive alendronate sodium 70 mg tablet (Ostomod, Modava company) with 70mg/week (one tablet at week)dose orally for 12 months. Alendronate is a bisphosphonate which binds to the

Sponsors

Vice chancellor for research, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Schober index=5; Normal hip joint in the pelvic radiography; Absence or rarity of syndesmophyte in the spine radiography (Taylor index=1); Normal bone density or mild osteopenia (T-score=-1.5) Exclusion criteria: Use of drugs which increase bone density like bisphosphonates; Use of steroids and biological agents; Coexistence of other disease which decreases bone density: including hyperparathyroidism, diabetes, hyper and hypothyroidism, osteomalasia, liver failure, renal failure

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Bone density. Timepoint: 12 months after intervention (at the end of study). Method of measurement: Bone mineral density measurement as gram/cm² by the DEXA method with Hologic QRD model instrument from lumbar and pelvic area.

Secondary

MeasureTime frame
Osteoporotic fracture. Timepoint: Every 3 months until 12 months. Method of measurement: History, physical examination, and radiography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrzad Hajiallilo

Tabriz University of Medical Sciences

hajialilo@gmail.com+98 41 1337 3966

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026