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The effects of alendronate and Vitamin K on postmenopausal osteoporosis

The effects of alendronate and Vitamin K Combination versus Alendronate alone on bone mineral density of patients with postmenopausal osteoporosis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201504141479N3
Enrollment
50
Registered
2015-08-17
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

Osteoporosis. postmenopausal osteoporosis

Interventions

Intervention 1: Group 1 will receive calcium + vitamin D pills twice daily (Jalinous company, Tehran, Iran, each pill contains 500 mg calcium carbonate and 200 IU vitamin D) and 70mg alendronate orall
Dr. Abidi Company, Tehran, Iran). The duration of treatment will be one year. Intervention 2: Group 2 will receive calcium + vitamin D pills twice daily (Jalinous company, Tehran, Iran, each pill cont
Dr. Abidi Company, Tehran, Iran) and vitamin K1 pills 10 mg daily (Pars Minoo Ind. Company, Tehran, Iran). The duration of treatment will be one year.
Treatment - Drugs
Group 1 will receive calcium + vitamin D pills twice daily (Jalinous company, Tehran, Iran, each pill contains 500 mg calcium carbonate and 200 IU vitamin D) and 70mg alendronate orally per week (Alen
Dr. Abidi Company, Tehran, Iran). The duration of treatment will be one year.
Group 2 will receive calcium + vitamin D pills twice daily (Jalinous company, Tehran, Iran, each pill contains 500 mg calcium carbonate and 200 IU vitamin D), 70mg alendronate orally per week (Alenate

Sponsors

Vice president for research, Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- Osteoporosis according to WHO Criteria 2-Age:45-65 years 3- Postmenopausal women Exclusion criteria 1- Secondary Osteoporosis 2- Taking anticoagulants 3- History of liver and kidney disorders 4- History of Bisphosphonates side effects 5- People who have contraindications to take calcium and vitamin D 6- People who take other anti- osteoporotic medications 7- People who needs to use Vit.K in the alendronate group

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Bone mineral density. Timepoint: Before the intervention and one year later. Method of measurement: By Densitometery with DXA method.

Secondary

MeasureTime frame
Drug side effects. Timepoint: Every 2 months. Method of measurement: Taking history.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hassan Jokar

Imam Reza Hospital

jokarmh@mums.ac.ir+98 51 3859 8818

Outcome results

None listed

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