Related Experiment Video
Updated: Feb 19, 2026
04:20
Author Spotlight: Enhancing Accuracy and Reproducibility in Whole Bone Bending Tests
Published on: September 1, 2023
1.5K
Bone Therapeutics: Safety Considerations, Session Summary
Christopher P Jerome1, Rogely Boyce2
11 Wake Forest Innovations, Winston-Salem, North Carolina, USA.
Toxicologic Pathology
|November 8, 2017
Summary
This review discusses safety considerations for bone therapeutic agents, covering bone resorption inhibitors and bone formation stimulators. It highlights regulatory requirements, toxicology, clinical findings, and challenges in treating rare genetic bone diseases.
Area of Science:
- Pharmacology and Toxicology
- Bone Biology
- Regulatory Science
Background:
- Bone therapeutics are crucial for treating osteoporosis and other bone diseases.
- Safety assessment is paramount for both nonclinical and clinical development of bone agents.
- Regulatory requirements and evolving therapeutic modalities necessitate continuous evaluation of safety profiles.
Purpose of the Study:
- To review safety considerations for bone therapeutic agents.
- To discuss regulatory requirements for nonclinical safety studies.
- To highlight safety issues associated with bone resorption inhibitors and bone anabolic agents.
Main Methods:
- Overview of regulatory requirements for bone quality assessment.
- Review of general and reproductive toxicology studies for bone resorption inhibitors.
- Analysis of clinical safety data for marketed bone therapeutic agents.
- Discussion of carcinogenicity risk assessment for bone anabolic agents.
- Introduction to developmental challenges for rare genetic bone disease therapeutics.
Main Results:
- Key safety considerations for bone resorption inhibitors include findings from toxicology studies and clinical experience.
- Carcinogenicity risk assessment is a major focus for bone anabolic agents.
- Novel therapeutic modalities for rare genetic bone diseases present unique developmental challenges.
Conclusions:
- Comprehensive safety evaluation is essential throughout the lifecycle of bone therapeutic agents.
- Understanding and addressing safety concerns guides regulatory submissions and clinical practice.
- Advancements in bone therapeutics require ongoing research into efficacy and safety, particularly for rare diseases.
Related Concept Videos
01:29Bone Disorders
5.6K
Aging and its effect on bone remodeling is the most common cause of bone disorders. In young and healthy people, bone deposition and resorption happen at an equal rate to maintain optimal bone health.
Bone deposition is also affected by the levels of sex hormones like estrogen and testosterone that promote osteoblast activity and bone matrix synthesis. When the level of these hormones decreases due to aging, it causes a reduction in bone deposition. As a result, bone resorption by osteoclasts...
Bone deposition is also affected by the levels of sex hormones like estrogen and testosterone that promote osteoblast activity and bone matrix synthesis. When the level of these hormones decreases due to aging, it causes a reduction in bone deposition. As a result, bone resorption by osteoclasts...
5.6K
01:27Fractures: Bone Repair
5.7K
Treatment for a fracture is based on the type of break, the bone affected, and the patient's age.
Minor fractures with no bone displacement are treated by immobilizing the fractured bone using a cast or splint. However, in the case of fractures with displaced bones, the broken bones are repositioned before immobilization to ensure successful healing without deformation and loss of function. The realignment of fractured bone ends is performed through a process called reduction. If the...
Minor fractures with no bone displacement are treated by immobilizing the fractured bone using a cast or splint. However, in the case of fractures with displaced bones, the broken bones are repositioned before immobilization to ensure successful healing without deformation and loss of function. The realignment of fractured bone ends is performed through a process called reduction. If the...
5.7K
01:29Blood and Nerve Supply to the Bones
14.1K
Bones are dynamic organs that require a rich supply of oxygen and nutrients. Around 5% to 10% of the cardiac output supplies blood to the bones. A typical long bone has three main sources: the nutrient artery, the metaphyseal and epiphyseal arteries, and the periosteal arteries.
Nutrient Artery
The nutrient artery is the main blood vessel that enters the diaphysis via the nutrient foramen. While most long bones have only one nutrient foramen, large bones, such as the femur, may have two. This...
Nutrient Artery
The nutrient artery is the main blood vessel that enters the diaphysis via the nutrient foramen. While most long bones have only one nutrient foramen, large bones, such as the femur, may have two. This...
14.1K
01:55Bone Structure
52.1K
Within the skeletal system, the structure of a bone, or osseous tissue, can be exemplified in a long bone, like the femur, where there are two types of osseous tissue: cortical and cancellous.
52.1K
01:40Bone Remodeling
40.6K
Bone remodeling is a continuous and balanced process of bone resorption by osteoclasts and bone formation by osteoblasts. In adults, it helps maintain bone mass and calcium homeostasis. While mechanical stress can stimulate turnover as part of the normal maintenance and reparative process, several hormones also regulate bone remodeling.
40.6K