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alendronate

Generic: ALENDRONATE SODIUM·Brand: ALENDRONATE SODIUM, BINOSTO, Binosto, FOSAMAX, Fosamax, Fosamax Plus D

alendronate: developed by 1 company · 2 clinical trials tracked · 1 FDA decision.

alendronate evidence translation

What we can confirm

1 FDA record · 2 tracked trials

What it means

Source-backed records connect alendronate to TEVA; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could alendronate → TEVA affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 0 study sponsors

Related indications

HIV InfectionsOsteoporosis

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
Teva Pharmaceutical Industries Limited (TEVA)Approved
Clinical Trials (2)

Investigating the Efficacy of Romosozumab in Augmenting Bone Density and Muscle Mass to Enhance the Outcomes of Spine Surgery

NCT06973109·Phase 2
Withdrawn

Primary endpoint: Change in Hounsfield Units (HU) at L1 Vertebra

InterventionalRandomizeddouble0 targetStarted 2026-06Completion 2027-061 site · United StatesUniversity of Pittsburgh

Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir

NCT00120757·Phase 3
Completed

Primary endpoint: Percentage of variation of lumbar BMD on DEXA scan at month 24 versus month 0 for patients included with lumbar osteoporosis (femoral for those included with only femoral osteoporosis)

InterventionalRandomizeddouble140 enrolledStarted 2004-10Completion 2008-113 sites · FranceFrench National Agency for Research on AIDS and Viral Hepatitis
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE Alendronate sodium is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women ( 1.1 , 1.2 ) Treatment to increase bone mass in men with osteoporosis ( 1.3 ) Treatment of glucocorticoid-induced osteoporosis ( 1.4 ) Treatment of Paget's disease of bone ( 1.5 ) Limitations of use: Optimal duration of use has not been determined. For patients at low- risk for fracture, consider drug discontinuation after 3 to 5 years of use. (1.6) 1.1 (TEVA)FDA ↗
ANDA076184OralTablet

Frequently asked questions

Who is developing alendronate?

alendronate is being developed by Teva Pharmaceutical Industries Limited.

How many clinical trials involve alendronate?

BioSniper tracks 2 clinical trials involving alendronate.

What is alendronate's latest FDA decision?

The most recent tracked FDA decision for alendronate is Approval for 1 INDICATIONS AND USAGE Alendronate sodium is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women ( 1.1 , 1.2 ) Treatment to increase bone mass in men with osteoporosis ( 1.3 ) Treatment of glucocorticoid-induced osteoporosis ( 1.4 ) Treatment of Paget's disease of bone ( 1.5 ) Limitations of use: Optimal duration of use has not been determined. For patients at low- risk for fracture, consider drug discontinuation after 3 to 5 years of use. (1.6) 1.1 , dated February 6, 2008.