A 15-week, double-blind, randomized, active-controlled, multicenter study to evaluate the efficiency and safety of Alendronate plus Vitamin D3 in the prevention of Vitamin D3 insufficiency and deficiency in women with osteoporosi

• Conditions: Treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency.; MedDRA version: 14.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2010-024150-10-PL
• Lead Sponsor: Teva Pharmaceutical Industries Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-11
• Last Update Posted: 12 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 630

Inclusion Criteria

1. 18 years and older
2. Patients in good general health, according to the investigator?s judgment
3. Serum 25-hydroxy vitamin D =9 ng/ml
4. Normal (within reference range) iPTH and BSAP for patients with serum 25-hydroxy vitamin D =9 ng/ml and <15 ng/ml
5. Postmenopausal women defined as one of the following: - more than 6 months amenorrhea in patients =55 years OR - more than 18 months amenorrhea in patients <55 years OR - baseline serum FSH >35 IU/l in patients <55 years and less than 18 months amenorrhea OR - surgical menopause since more than 4 weeks.
6. Recent (within the last 6 months) bone mineral density (BMD) Tscore determined by dual energy X-ray absorptiometry (DEXA) of either lumbar spine or hip of = -2.5 (=2.5 standard deviations below the mean for normal postmenopausal women)
7. Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
8. Patient agrees to avoid tanning beds/UV therapy within 14 days of study start, and during the study
9. Patients with ability to follow study instructions and likely to attend and complete all required visits
10. Written informed consent of the patient
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 630
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 630

Exclusion Criteria

1. Hypersensitivity to the active substances or to any of the excipients, or to any related drug
2. Bone fractures within 3 months prior to screening
3. Inability to stand or sit upright for at least 30 minutes
4. Inability to take the study drugs as recommended: after getting up for the day with a full glass of water (not less than 200 ml)
5. Active upper gastrointestinal problems, such as dysphagia, esophageal disease, gastritis, duodenitis, ulcers
6. Recent history (within the previous year) of major gastrointestinal disease such as peptic ulcer, or active gastrointestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty
7. Known Barrett's esophagus
8. Malabsorption
9. Hypocalcemia: serum calcium <2.1 mmol/l (9 mg/dl)
10. Concomitant malignancy except carcinoma in situ not needing other than local therapy
11. History of solid tumors not curatively treated or showing a recurrence within the last 5 years
12. Concomitant untreated severe periodontal disease
13. Renal impairment (glomerular filtration rate less than 35 ml/min)
14. Presence of bone or mineral metabolism disorders, other than idiopathic osteoporosis (e.g. hyperparathyroidism, hyperthyroidism, osteomalacia of other origin, Paget?s disease of bone, glucocorticoid-induced osteoporosis)
15. Diseases associated with unregulated overproduction of calcitriol (e.g. leukemia, lymphoma, sarcoidosis).
16. Previous or concomitant intake of drugs and/or food additives restricted by the protocol (for a complete list please see chapter 8.6.6, page 38).
17. Pregnancy or lactation
18. Simultaneous participation in another clinical study or participation in any clinical study involving an investigational drug within 3 months prior to start of the present study
19. Severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol
20. History of alcohol or drug addiction
21. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
22. Unreliability or lack of cooperation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified