Alendronic acid

Generic Name: Alendronic acid

Brand Names: Adrovance, Binosto, Fosamax, Fosamax Plus D, Fosavance

Drug Type: Small Molecule

Chemical Formula: C_₄H_₁₃NO_₇P_₂

CAS Number: 66376-36-1

Unique Ingredient Identifier: X1J18R4W8P

Background: Alendronic acid is a second generation bisphosphonate that is used for the treatment of some forms of osteoperosis and Paget's disease. It functions by preventing resorption of bone.

Indication: Alendronic acid is indicated for the treatment and prevention of osteoporosis in men and postmenopausal women, treatment of glucocorticoid-induced osteoporosis, and Paget's disease of bone. However, alendronic acid is not indicated for use in pediatric populations or patients with a creatinine clearance <35mL/min.

Associated Conditions: Osteogenesis Imperfecta (OI), Osteoporosis, Osteoporosis caused by Glucocorticoid Treatment, Paget’s Disease

Associated Therapies: -

Clinical Trials

FOSAMAX PLUS and FOSAMAX PLUS D Re-examination Study (0217A-267)

Completed

Conditions: Osteoporosis

Interventions: Drug: FOSAMAX PLUS
Drug: FOSAMAX PLUS D

First Posted Date: 2010-02-09

Last Posted Date: 2022-02-03

Lead Sponsor: Organon and Co

Target Recruit Count: 880

Registration Number: NCT01065779

Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis

Not Applicable

Completed

Conditions: Osteoporosis

Interventions: Drug: alendronate

First Posted Date: 2009-07-10

Last Posted Date: 2009-07-10

Lead Sponsor: Ciudad Universitaria, Spain

Target Recruit Count: 228

Registration Number: NCT00936260

Locations: 🇪🇸
University San Carlos Hospital, Madrid, Spain

Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents

Phase 2

Completed

Conditions: HIV Infection

Interventions: Drug: Alendronate
Drug: Placebo
Dietary Supplement: Calcium carbonate/vitamin D

First Posted Date: 2009-06-16

Last Posted Date: 2021-11-05

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 52

Registration Number: NCT00921557

Locations: 🇺🇸
Lurie Children's Hospital of Chicago (LCH) CRS, Chicago, Illinois, United States
🇺🇸
Pediatric Perinatal HIV Clinical Trials Unit CRS, Miami, Florida, United States
🇺🇸
WNE Maternal Pediatric Adolescent AIDS CRS, Worcester, Massachusetts, United States

and more 7 locations

Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density

Phase 2

Completed

Conditions: Low Bone Mineral Density
Postmenopausal Osteoporosis

Interventions: Drug: Placebo to Romosozumab
Drug: Romosozumab
Drug: Alendronate
Drug: Teriparatide
Drug: Denosumab
Drug: Placebo to Denosumab
Drug: Zoledronic acid

First Posted Date: 2009-05-11

Last Posted Date: 2022-09-22

Lead Sponsor: Amgen

Target Recruit Count: 419

Registration Number: NCT00896532

Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy

Phase 3

Terminated

Conditions: Osteoporosis
Cerebral Palsy

Interventions: Drug: FOSAMAX
Other: PLACEBO

First Posted Date: 2009-01-14

Last Posted Date: 2012-03-26

Lead Sponsor: Department of Clinical Research and Innovation

Target Recruit Count: 2

Registration Number: NCT00822029

Locations: 🇫🇷
Chirurgie Infantile - Hôpital ARCHET, Nice, France

The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)

Phase 4

Terminated

Conditions: Back Pain

Interventions: Drug: Parathyroid hormone (PTH) (1-84)
Drug: Alendronate

First Posted Date: 2008-07-11

Last Posted Date: 2012-05-08

Lead Sponsor: Nycomed

Target Recruit Count: 75

Registration Number: NCT00713258

Locations: 🇩🇰
Nycomed, Roskilde, Denmark

Cyclic Versus Daily Teriparatide on Bone Mass

Phase 2

Conditions: Osteoporosis

Interventions: Drug: Teriparatide
Drug: Alendronate
Dietary Supplement: Calcium
Dietary Supplement: Vitamin D3

First Posted Date: 2008-04-29

Last Posted Date: 2017-08-10

Lead Sponsor: Helen Hayes Hospital

Target Recruit Count: 140

Registration Number: NCT00668941

Locations: 🇺🇸
Helen Hayes Hospital, West Haverstraw, New York, United States

Bisphosphonate Action on the Appendicular Skeleton: Evidence for Differential Effects

Phase 2

Completed

Conditions: Post-menopausal Osteoporosis

Interventions: Drug: Ibandronate
Drug: Risedronate
Drug: Alendronate

First Posted Date: 2008-04-25

Last Posted Date: 2018-03-06

Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Target Recruit Count: 410

Registration Number: NCT00666627

Locations: 🇬🇧
Academic Unit of Bone Metabolism (Sheffield), Sheffield, South Yorkshire, United Kingdom

Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants

Not Applicable

Completed

Conditions: Renal Insufficiency

Interventions: Drug: Zoledronic Acid
Combination Product: Calcium with vitamin D
Drug: Alendronate

First Posted Date: 2007-12-24

Last Posted Date: 2023-10-04

Lead Sponsor: University of Nebraska

Target Recruit Count: 59

Registration Number: NCT00580047

Locations: 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States

Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose

Phase 1

Completed

Conditions: Osteopenia
Osteoporosis

Interventions: Drug: alendronate
Drug: risedronate

First Posted Date: 2007-12-20

Last Posted Date: 2013-04-17

Lead Sponsor: Warner Chilcott

Target Recruit Count: 32

Registration Number: NCT00577850

Locations: 🇺🇸
Research Facility, Gainesville, Florida, United States
🇺🇸
Research Site, New Orleans, Louisiana, United States

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