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Musculoskeletal Health

Musculoskeletal Health

Research

Clinical Trials

Current Open Trials

Pfizer A4091058

A Phase 3 Randomized, Double-Blind, Active-Controlled, Multicenter Study of the Long-Term Safety and Efficacy of Subcutaneous Administration of Tanezumab in Subjects with Osteoarthritis of the Hip or Knee

UC Davis researchers are looking for patients with Osteoarthritis (OA) of the hips or knees.

 The purpose of this research study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti-inflammatory drugs (NSAIDs) in subjects with OA of the hips or knees.

 Eligibility Criteria:

1.    Have OA in at least one hip or knee

2.    18 years of age or older

3.    Currently taking the following NSAIDs: naproxen, celecoxib, or diclofenac

 Treatment Protocol:

Subject will be randomly assigned to receive active NSAID plus placebo tanezumab or placebo NSAID plus active tanezumba (2.5mg) or placebo NSAID plus active tanezumab (5 mg).

 If selected to participate in the study, subjects will receive a modest compensation for time and travel.

 Length of Study: 21 months

 

Bisphosphonate Drug Holiday Study

A multi-center observational study using biochemical markers of bone turnover to monitor the effects of a bisphosphonate drug holiday

Bisphosphonates such as alendronate (Fosamax) and risedronate (Actonel) are widely used in the prevention and treatment of osteoporosis in postmenopausal women and older men. Recently there has been concern about the risk of adverse events after several years of using these agents.  For some patients, a holiday from bisphosphonates might be considered after 4-5 years of continuous use.

The purpose of this study is to use blood tests of biochemical markers of bone turnover (proteins that are released into the blood during bone formation or bone breakdown) to establish when patients who are on a bisphosphonate drug holiday may begin to lose bone mass again.

Eligibility Criteria:
You may qualify to participate in this study if you are:

•    A postmenopausal woman or man > 50 years old

•    Willing to complete up to 10 study visits at the UC Davis Medical Center. (Visits will be approximately 2 hours each)

•    Have taken oral alendronate (Fosamax) or risedronate (Actonel) for five or more years, and if your doctor is agreeable to starting a drug holiday from this medication

Treatment Protocol:
Subjects going on a bisphosphonate drug holiday will be monitored over a 2 year period. Subjects will provide a blood sample every 3 months. Bone density (via DXA scans) will be measured at baseline, 12 months and 24 months.

If accepted into the study, you will receive study related medical exams, lab tests and DXA scans and a modest compensation for time and travel.

Length of study: 2 years

 

AbbVie M14-171

This study is closed to enrollment

A Phase 2a, Multicenter, Randomize, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-981 to Placebo in Subjects with Erosive Hand Osteoarthritis

UC Davis researchers are looking for patients with Osteoarthritis (OA) of the hand.

The purpose of this study is to evaluate the effectiveness of the drug ABT-981 in decreasing pain and inflammation in patients with erosive hand OA.

ABT-981 is a new type of antibody that blocks two different proteins, IL-1α and IL-1β, which play a major role in the development and progression of Osteoarthritis (OA). ABT-981 has been studied in healthy volunteers, as well as in subjects with OA of the hand.

Eligibility Criteria:
1.    Have pain and erosive OA in at least one hand

2.    Are 35-80 years old

3.    Willing to complete up to 8 months of study visits at the UC Davis Medical Center

4.    Body weight is less than 300 lbs.

Treatment Protocol:
Subject will be randomly assigned to receive either ABT-981, or placebo injections into the abdomen. There is a 50% chance of receiving the drug.

If selected to participate in the study, subjects will receive a modest compensation for time and travel.

Length of Study: 8 months


AbbVie M13-741

This study is closed to enrollment

A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients with Knee Osteoarthritis

UC Davis researchers are looking for patients with Osteoarthritis (OA) of the knee.

The purpose of this study is to assess the effectiveness of the drug ABT-981 in decreasing pain and inflammation in patients with OA of the knee.

ABT-981 is a new type of antibody that blocks two different proteins, IL-1α and IL-1β, which play a major role in the development and progression of Osteoarthritis (OA). ABT-981 has been studied in healthy volunteers, as well as in subjects with OA of the knee.

Eligibility Criteria:
1.    Have pain in at least one knee
2.    Are 35-74 years old
3.    Willing to complete up to 1 year of study visits at the UC Davis Medical Center
4.    Body weight is less than 300 lbs

Treatment Protocol:
Subject will be randomly assigned to receive either ABT-981, or placebo injections into the abdomen. There is a 75% chance of receiving the drug.
If selected to participate in the study, subjects will receive a modest compensation for time and travel.

Length of Study: 1 year


Myoscience

This study is closed to enrollment

A Multi-Center, Prospective, Double-Blind, Randomized Controlled Study to Evaluate the Effectiveness and Safety of the iovera‚ó¶ Device for the Temporary Relief of Pain Associated with Knee Osteoarthritis

UC Davis researches are looking for patients with Osteoarthritis (OA) of the knee.

The purpose of this study is to evaluate the effectiveness of a cold therapy device for the temporary reduction of pain associated with knee OA. The cryotherapy targets nerve tissue, providing pain relief for up to 180 days.

Eligibility Criteria:
1.    Have OA in at least one knee
2.    Are 35-75 years old
3.    Willing to complete up to 11 study visits at the UC Davis Medical Center

Treatment Protocol:
Subjects will be randomly assigned to receive either cold therapy or placebo, administered by the cold therapy device. This treatment procedure uses three micro needles inserted into the knee to initiate the cooling cycle. The remaining visits will consist of questionnaires and other follow-up procedures.
If selected to participate in the study, subjects will receive a modest compensation for time and travel.

Length of Study: 6 months


Amgen 162

This study is closed to enrollment

A Phase 3 Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

Glucocorticoid medications are used to help control many chronic inflammatory conditions, but can have a negative effect on bone tissue that can lead to bone loss—a condition called glucocorticoid-induced osteoporosis (GIOP). If you are taking a glucocorticoid medication such as prednisone or cortisone, you may be eligible to participate in this trial.

The purpose of this study is to find out if a drug called denosumab is safe and effective in people who have osteoporosis or are at risk of developing osteoporosis as a result of taking glucocorticoids. The primary objective of this trial is to evaluate the effectiveness and safety of an FDA approved drug, denosumab, compared to another FDA approved drug, risedronate.

Denosumab is a fully human monoclonal antibody designed to target a protein that acts as the primary signal for bone removal and overwhelms the body’s natural defenses against bone destruction, whereas risedronate is a bisphosphonate that strengthens bone by inhibiting bone removal by osteoclast.

Eligibility Criteria:

  1. Male or Female aged 18 years or older
  2. Taking 7.5 mg or more of glucocorticoid therapy and are expected to continue receiving it for at least 6 months
  3. Have not used denosumab for osteoporosis at any time in the past

Treatment Protocol:
Subject will be randomly assigned to have a denosumab injection every 6 months and an oral placebo for risedronate daily for 24 months or oral risedronate daily and a placebo of the denosumab  injection every 6 months for 24 months.

If selected to participate in the study you will need to visit our clinic 7 times over the next 6 months, then once every 6 months for 3 visits until month 24.

Length of Study: 2 years


Orthotrophix 100

This study is closed to enrollment

A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects with Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees

UC Davis researchers are looking for patients with Osteoarthritis (OA) in both knees.

The purpose of the study is to learn more about the drug TPX-100, a synthetic peptide derived from human protein believed to stimulate precursor cells to form hyaline cartilage.  TPX-100 represents a first-in-class and first-in-indication, disease-modifying agent administered via injection to the knee.

TPX-100 has been shown to stimulate tissue-appropriate regeneration of dentin (a calcified tissue of the body), bone, and cartilage. Successful clinical development of TPX-100 can be expected to significantly reduce the disability associated with knee OA and create a treatment option to be considered before, or instead of, surgery.

Eligibility Criteria:
1.    Have pain in both knees
2.    Are 25 to 75 years old
3.    Willing to complete up to 9 study visits at the UC Davis Medical Center over the period of one year
4.    Body weight is less than 300 lbs

Treatment Protocol:
Subject will receive the drug TPX-100 in one knee and a placebo in the other knee via intra-articular injection, administered once-weekly for 4 weeks.  Study subjects will attend 3 follow up visits during the 12 month trial.
If selected to participate in the study, subjects will receive a modest compensation for time and travel.

Length of Study: 1 year

 

Amgen 785

This study is closed to enrollment

A Phase 3 Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis

UC Davis researchers are looking for women with postmenopausal osteoporosis.

The purpose of the study is to learn more about the drug Romosozumab in women with postmenopausal osteoporosis.  This study will see if Romosozumab prevents fractures of the bone and whether it causes any side effects.

Romosozumab is a monoclonal antibody delivered via injection that is designed to increase bone formation by inhibiting a protein associated with bone loss.

You will also be provided with calcium and vitamin D supplements for the duration of the study.

Eligibility Criteria:

  1. Have postmenopausal osteoporosis
  2. Are 55 to 90 years old
  3. Have not had a hip fracture
  4. Are not taking any medication for osteoporosis other than calcium and vitamin D

Treatment Protocol:
Subject will receive either Romosozumab by subcutaneous injection every month or an identical appearing placebo by subcutaneous injection every month for the duration of 11 months.

For the second year of the study, all subjects will be treated with a Denosumab injection at month 12 and month 18.

If selected to participate in the study you will need to visit our clinic every month for one year and then 4 visits during the second year.

Length of Study: 2 years

 

 

Become a Participant

To learn about how to participate in a clinical trial, please contact us at:

UC Davis Center for Musculoskeletal Health
4625 2nd Ave., Suite 2000
Sacramento CA 95817

Telephone: 916-734-3011
Fax: 916-734-0901
Facebook: Center for Musculokeletal Health UC Davis Medical Center
Email: CMHClinicalTrials@ucdmc.ucdavis.edu

 

 

Past Trials and Findings

Teva 45070

This study is closed to enrollment

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (4% and 8% w/w Ointment) in Patients with Primary Osteoarthritis Affecting a Single Knee

The purpose of the study is to learn more about the effectiveness of the drug TV-45070 in reducing knee pain in subjects with Osteoarthritis (OA) of the knee. TV45070 is an ointment belonging to the drug class known as sodium channel blockers which interferes with the transmission of pain impulses in the nerves.

Xoma

This study is closed to enrollment

A Phase 2 Proof-of-concept Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand

The primary objective of this trial is to find out more about a clinical trial drug called Gevokizumab.

Gevokizumab is a monoclonal antibody meant to limit the action of specific proteins in body that release and cause inflammation.

The purpose of this study is to determine what side effects the drug may cause, and whether the drug is useful to treat and help relieve the signs and symptoms of Erosive Osteo-Arthritis of the Hand.


Knee Osteoarthritis Tanezumab

The primary objective of this trial was to evaluate the effectiveness and safety of an investigational new drug called Tanezumab and whether it helps relieve the signs and symptoms of knee osteoarthritis.  Tanezumab is an antibody.  An antibody is a type of protein that is produced by the immune system to help protect the body against foreign compounds.  Tanezumab acts against another protein, called human nerve growth factor (NGF).  NGF is a natural compound that’s made by the body and is involved in causing a person to feel pain.  It is thought that the binding of tanezumab to NGF can block NGF activity, reducing the subject’s pain.

http://www.ucdmc.ucdavis.edu/publish/news/newsroom/4365